Tevapharm
Runcorn, Cheshire
Associate Director, Global Quality Compliance TORCH Location: Runcorn, United Kingdom, WA7 3FA Job Id: 65648 Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity The main purpose of this role is to act as a subject matter expert and compliance leader in the newly-formed Teva Operations Regulatory Compliance Hypersupport (TORCH) internal and external manufacturing teams. This highly experienced quality, compliance and operations leader will be responsible for driving the activities of the TORCH team who collectively partner with TGO site leaders in Quality, Compliance and Operations to ensure proper quality compliance risk identification and mitigation of patient product supply risks, problem solving quality-related issues, vital Pivot to Growth transformation and TGO modernization projects, inspection readiness, inspection support and follow-up. This role will interact across the TGO network supply sites working with our internal Manufacturing Sites, External Manufacturing Quality, R&D Quality, Commercial Quality, MS&T, R&D, Supply Chain Operations, Procurement, Regulatory, Pharmacovigilance, Medical and others. In some instances, this role will entail global compliance quality oversight and governance in strong collaboration with manufacturing operations to ensure excellence in inspection readiness and successful inspection management at critical internal and external supply sites. Location This role can be based in any Teva TGO (Teva Global Operations) Location in Europe. Travel Up to 50% international travel expected (HQs, internal sites, additional required meetings, etc.) How you'll spend your day Act and behave in accordance with Teva's values and leadership standards. Targeted support based on critical business needs and potential risks. Global Projects improving patient supply and quality compliance of our sites, processes, and systems; for example: inspection management and readiness programs, significant event scoping and resolution, deviation quality compliance derisking, building a strong partnership with operations and training of SMEs to ensure successful regulatory inspections, a mature Quality and Compliance mindset and culture of Quality. Inspection readiness & inspection management include, but not limited to preparation of subject matter experts, coaching, shop floor Gemba, back-room strategy, site remediation and investigative protocols, inspection response co-writing & review, and CAPA / CAPA effectiveness monitoring and verification. Product quality incident management oversight and monitoring. Leads multi-cross site investigations. Provide guidance to ensure compliance with Teva's global standards, regulatory guidelines, and cGMP requirements. Foster and Promote Communication, Harmonization, and Support across supply operations. Support/lead Global Quality Compliance Initiatives, i.e. develop and contribute to Teva's Long Range Plan and Global Quality Compliance Initiatives. Support critical product incident management events; may include complex investigations at the sites ensuring comprehensive, scientific, well written investigations utilize robust root cause analysis tools with appropriate CAPA to prevent regulator enforcement actions whereby mitigating risk to Teva. With respect to quality compliance derisking activities, for critical supply sites, review inspection readiness dashboard and self audit program schedule, trends/signals, and CAPA effectiveness verifying state of compliance. Inspection Management Support for Health Authority Inspections: may include evaluation, guidance, and support for successful Health Authority inspections such as preparation of inspection responses, post inspection support and monitoring of commitments. When needed, work collaboratively with the site compliance teams to perform activities such as floor and laboratory walk through. Work with sites to ensure mock audits of manufacturing, packaging, laboratory processes, procedures, and facilities meet their needs and verify a state of inspection readiness at the site. When needed, write or execute protocol for deep dive quality compliance assessments, conduct risk assessments, evaluate justification positions, support storyboards and prep SMEs for those incidents. Help create, where needed, review and monitor the Quality Improvement Plans (QIP) to minimize quality compliance risk and improve quality performance and KPI measures. Ensure Quality Risk Management is implemented effectively to assess, control, communicate, and review risks. Contribute to Teva's Global Compliance Network: Addresses and advises GxP regulation interpretation, Teva's Corporate Standards requirements, lessons learned and knowledge management of quality compliance events, risks, and practices as well as evolving regulation Your experience and qualifications Education: Bachelor's Degree - chemistry, microbiology, pharmacy, engineering, or related science-based degree Experience: 10+ years of experience as a functional leader with technical, team management, and operational responsibility. Continuous professional development. Ability to work with various organizational leadership levels and in a team environment across multiple roles. Multi and Intercultural sensibility is a key consideration supporting global operations. Excellent experience in Compliance and Health Authority interaction, leading inspection readiness activities and programs, compliance team leadership or quality unit leadership, successful outcomes delivered through a variety of roles in global regulatory inspections, successful product submissions and approvals, lifecycle management. Working knowledge of audit and inspection management, response writing and investigation, complaint, CAPA management programs required. Excellent interpersonal skills to collaborate across many levels and functions within Teva, ability to navigate changing priorities and deliverables, agile and flexible to respond to critical needs of the business, comfortable in working within a matrix environment. Functional / Industry Knowledge: Pharmaceutical Quality Manufacturing experience. Solids, Medical Device, Sterile, Biologics, Biosimilars Quality Compliance experience required. Strong practical knowledge pharmaceuticals manufacturing, contamination control, facility design, utilities, maintenance, and calibration. Adequate knowledge of local current and upcoming legislation and current Quality best practices, health regulations and guidance also essential. International experience is an advantage. Strong knowledge of cGMP requirements for products and processes. Solid understanding and insight into the different aspects of quality functions like Quality Control, Microbiology, Quality Assurance, Quality Systems, Quality Compliance, Documentation, etc. Strong knowledge of quality systems. Solid ability to understand, interpret, and execute in accordance with the Teva Quality Management System. Solid knowledge of MRP Systems and GMP impacting computer systems, like SAP, Empower, LIMS and software platforms typically used by Teva. Deep knowledge and experience in Auditing, Compliance and Quality Oversight Critical Capabilities Resilient and deep drive for continuous improvement and compliance. Energetic, committed to continuous improvement and problem solving. Strong project management, organizational skills to lead a dynamic team and change management. Proactive orientation, self motivated, flexible, and innovative way of thinking. Reports To Head of TORCH Already ? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process . click apply for full job details
Associate Director, Global Quality Compliance TORCH Location: Runcorn, United Kingdom, WA7 3FA Job Id: 65648 Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity The main purpose of this role is to act as a subject matter expert and compliance leader in the newly-formed Teva Operations Regulatory Compliance Hypersupport (TORCH) internal and external manufacturing teams. This highly experienced quality, compliance and operations leader will be responsible for driving the activities of the TORCH team who collectively partner with TGO site leaders in Quality, Compliance and Operations to ensure proper quality compliance risk identification and mitigation of patient product supply risks, problem solving quality-related issues, vital Pivot to Growth transformation and TGO modernization projects, inspection readiness, inspection support and follow-up. This role will interact across the TGO network supply sites working with our internal Manufacturing Sites, External Manufacturing Quality, R&D Quality, Commercial Quality, MS&T, R&D, Supply Chain Operations, Procurement, Regulatory, Pharmacovigilance, Medical and others. In some instances, this role will entail global compliance quality oversight and governance in strong collaboration with manufacturing operations to ensure excellence in inspection readiness and successful inspection management at critical internal and external supply sites. Location This role can be based in any Teva TGO (Teva Global Operations) Location in Europe. Travel Up to 50% international travel expected (HQs, internal sites, additional required meetings, etc.) How you'll spend your day Act and behave in accordance with Teva's values and leadership standards. Targeted support based on critical business needs and potential risks. Global Projects improving patient supply and quality compliance of our sites, processes, and systems; for example: inspection management and readiness programs, significant event scoping and resolution, deviation quality compliance derisking, building a strong partnership with operations and training of SMEs to ensure successful regulatory inspections, a mature Quality and Compliance mindset and culture of Quality. Inspection readiness & inspection management include, but not limited to preparation of subject matter experts, coaching, shop floor Gemba, back-room strategy, site remediation and investigative protocols, inspection response co-writing & review, and CAPA / CAPA effectiveness monitoring and verification. Product quality incident management oversight and monitoring. Leads multi-cross site investigations. Provide guidance to ensure compliance with Teva's global standards, regulatory guidelines, and cGMP requirements. Foster and Promote Communication, Harmonization, and Support across supply operations. Support/lead Global Quality Compliance Initiatives, i.e. develop and contribute to Teva's Long Range Plan and Global Quality Compliance Initiatives. Support critical product incident management events; may include complex investigations at the sites ensuring comprehensive, scientific, well written investigations utilize robust root cause analysis tools with appropriate CAPA to prevent regulator enforcement actions whereby mitigating risk to Teva. With respect to quality compliance derisking activities, for critical supply sites, review inspection readiness dashboard and self audit program schedule, trends/signals, and CAPA effectiveness verifying state of compliance. Inspection Management Support for Health Authority Inspections: may include evaluation, guidance, and support for successful Health Authority inspections such as preparation of inspection responses, post inspection support and monitoring of commitments. When needed, work collaboratively with the site compliance teams to perform activities such as floor and laboratory walk through. Work with sites to ensure mock audits of manufacturing, packaging, laboratory processes, procedures, and facilities meet their needs and verify a state of inspection readiness at the site. When needed, write or execute protocol for deep dive quality compliance assessments, conduct risk assessments, evaluate justification positions, support storyboards and prep SMEs for those incidents. Help create, where needed, review and monitor the Quality Improvement Plans (QIP) to minimize quality compliance risk and improve quality performance and KPI measures. Ensure Quality Risk Management is implemented effectively to assess, control, communicate, and review risks. Contribute to Teva's Global Compliance Network: Addresses and advises GxP regulation interpretation, Teva's Corporate Standards requirements, lessons learned and knowledge management of quality compliance events, risks, and practices as well as evolving regulation Your experience and qualifications Education: Bachelor's Degree - chemistry, microbiology, pharmacy, engineering, or related science-based degree Experience: 10+ years of experience as a functional leader with technical, team management, and operational responsibility. Continuous professional development. Ability to work with various organizational leadership levels and in a team environment across multiple roles. Multi and Intercultural sensibility is a key consideration supporting global operations. Excellent experience in Compliance and Health Authority interaction, leading inspection readiness activities and programs, compliance team leadership or quality unit leadership, successful outcomes delivered through a variety of roles in global regulatory inspections, successful product submissions and approvals, lifecycle management. Working knowledge of audit and inspection management, response writing and investigation, complaint, CAPA management programs required. Excellent interpersonal skills to collaborate across many levels and functions within Teva, ability to navigate changing priorities and deliverables, agile and flexible to respond to critical needs of the business, comfortable in working within a matrix environment. Functional / Industry Knowledge: Pharmaceutical Quality Manufacturing experience. Solids, Medical Device, Sterile, Biologics, Biosimilars Quality Compliance experience required. Strong practical knowledge pharmaceuticals manufacturing, contamination control, facility design, utilities, maintenance, and calibration. Adequate knowledge of local current and upcoming legislation and current Quality best practices, health regulations and guidance also essential. International experience is an advantage. Strong knowledge of cGMP requirements for products and processes. Solid understanding and insight into the different aspects of quality functions like Quality Control, Microbiology, Quality Assurance, Quality Systems, Quality Compliance, Documentation, etc. Strong knowledge of quality systems. Solid ability to understand, interpret, and execute in accordance with the Teva Quality Management System. Solid knowledge of MRP Systems and GMP impacting computer systems, like SAP, Empower, LIMS and software platforms typically used by Teva. Deep knowledge and experience in Auditing, Compliance and Quality Oversight Critical Capabilities Resilient and deep drive for continuous improvement and compliance. Energetic, committed to continuous improvement and problem solving. Strong project management, organizational skills to lead a dynamic team and change management. Proactive orientation, self motivated, flexible, and innovative way of thinking. Reports To Head of TORCH Already ? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process . click apply for full job details
Tevapharm
Runcorn, Cheshire
Select how often (in days) to receive an alert: Head of Quality Manufacturing, EU, India & LATAM Solids & LCO cluster Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity The role is accountable to lead and manage all quality activities in the cluster. This includes Quality oversight and support over Teva manufacturing sites, suppliers, and its Quality Compliance processes. The Quality oversight has to ensure the quality of our products, compliance with regulations, and that the products are developed, manufactured, and supplied in a timely manner, securing uninterrupted supply to internal and external customers. In addition, the role provides the management infrastructure and business processes which ensure that the right capabilities and capacity are in place to ensure quality compliant decisions, and inspection readiness is confirmed by successful authority inspections. The role also includes a responsibility for driving proactive quality risk management processes and mindset across the sites, fostering a culture of continuous improvement and risk based thinking. In addition, the incumbent is leading TEVA's offshoring centers for Stability Testing and PQR/APR Compilation. Location This role can be based in any Teva location in Europe. Travel 40 - 50% international travel expected. How you'll spend your day Lead the Site Quality Heads and their organizations in the manufacturing sites and ensures independent decision making related to product quality and Quality compliance aspects. Develop projects to simplify business processes in Quality in accordance with Teva's regulatory requirements and standards, driving the tools of the Teva Lean Management System and a proactive approach to risk management. Sponsor the execution of strategic compliance initiatives and remediation activities as applicable. Build and manage the appropriate infrastructure to manage and improve Quality relevant relations to external suppliers driving standardization and efficiencies. Ensure that Quality compliance is a critical parameter to secure supply for internal and external customers. Significantly influence strategy as it relates to the Quality function, local and global Quality compliance, Quality operations and Quality Relation management. Develop together with Quality Compliance strategic plans driving toward the achievement of company quality compliance, business and financial goals, monitored by key performing indicators and the adherence to well set targets and drive their execution. Support Operations strategic initiatives toward the achievement of the gross margin improvement program, through strong lean management approach across QA and QC (inc. Lean Labs in the QC operations), driven by a focus on proactive risk management and ICH principles. Ensures continuous improvement of the QMS at the sites. Foster the continuous improvement of the Quality culture in the organization. Lead an efficient Quality and manufacturing sites network, compliant with cGXP requirements of global regulatory agencies (FDA, EMA, ANVISA, MHRA, EAEU GMP, etc) and the Teva Quality Management System related to the development, manufacturing, packaging, testing, release and distribution of active pharmaceutical ingredients. Ensure the implementation and continuous improvement of the Teva Quality Management System at site level to ensure compliance with existing and evolving guidelines, to increase the efficiency of the quality processes and quality systems and to identify and execute corrective and preventive actions, where applicable to close gaps. Drive standardization and harmonization of best practices across the sites. Ensure sites inspection readiness, inspection management and in case of inspection observations, implementation of corrective and preventive actions in a timely manner meeting agencies expectation. Ensure that sufficient resources are made available. Ensure a strong deviation investigation management system is established and executed on site level, that identifies and investigates quality deviations to root cause, defines appropriate CAPAs, ensures CAPA effectiveness and timely reporting in accordance with regulatory requirements. Support direct handling and resolution of severe quality incidents. Foster the identification of best practices and state-of-the art technologies. Facilitate and monitor their implementation. Develop and lead optimization and efficiency processes. Ensure knowledge management across the network, share inspection / audit findings and knowledge to ensure timely site-based assessments and the identification of actions to prevent future or repeat findings. How you'll spend your day Oversee the Stability Testing, including: Performance of stability tests in TEVA's offshore-centers (Zagreb, Goa) with registered methods per yearly ongoing stability program (OGS) or after significant changes of the MA (ICH). Ensure that Product Robustness issues are addressed, and the root cause of Compliance issues are identified and remediated. Ensure that the necessary AMTs were performed successfully. Ensure that necessary method adoptions / re developments are initiated, if a certain analytical method is not stability indicating. Development and validation of stability indicating Methods as Service provider for TEVA sites or TPO. Storage and sampling of stability samples as per stability plan defined by the product owner (e.g. TEVA site). Coordination of testing, shipping and storage between the different TEVA Sites, EMSO suppliers and the Offshoring Centers. Identify Cost saving opportunities such as reduced testing, and use of Global Business Services (GBS), APRs/PQRs. Oversee the delivery of APR/PQRs by ensuring the planning, establishment, and management of work plans, required resources (headcount, expense, and capital) and expected capabilities to meet existing and future business needs. Ensure EHS&S mindset across the quality operations and laboratories in the cluster sites, and a proactive risk management approach to safety. Lead, mentor, and develop a high performing global team, promoting collaboration and innovation fostering a culture of accountability, professional growth, & employee engagement. Guides team members' professional growth and development and support selection of key quality resources. Your experience and qualifications Education/Qualifications Minimum of 15 years pharmaceutical manufacturing multiples sites quality operations and leadership experience. Direct interaction with health authorities. Experience working in a large, complex matrixed environment with global processes & governance structures; practical knowledge of pharmaceuticals manufacturing and/ or control. Practical knowledge of analytical techniques and microbiological principles practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering). Product and technology transfer. Critical Skills/Capabilities: Professional: Practical knowledge of Global Compliance and Regulatory requirements, Industry guidelines (e.g. ICH guidelines specifically M7, PIC/s, PDA), cGxP: Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice and other guidelines, the regulations of supervisory authorities at local and international level, specifically US FDA, EMA, etc. Practical knowledge in manufacturing, testing and health authority inspections and expectations for the dosage form in the site network. Ability to develop and execute Strategic / Long Range and Annual Business Plans Practical knowledge on risk management. OpEx and LMS. Essential: Strong critical thinking / problem solving skills to navigate ambiguous situations; Strategic thinking; Excellent storytelling and presentation skills; Cross functional collaboration and stakeholder management; Effective communication; Strong relationship and senior stakeholder management capabilities. Leadership: Strong leadership, change management & influencing skill ; Decision making under uncertainty skills; Ability to drive transformational change in a large/global/matrixed environment; Proven talent management & people development capabilities (incl. coaching and mentoring); Ability to create an engaging & inclusive work climate and a culture of appreciation and trust; Ability to set a vision and drive organizational change and innovation; Ability to manage effectively complexity within the organization (shifting timelines, projects, priorities). Already ? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority . click apply for full job details
Select how often (in days) to receive an alert: Head of Quality Manufacturing, EU, India & LATAM Solids & LCO cluster Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity The role is accountable to lead and manage all quality activities in the cluster. This includes Quality oversight and support over Teva manufacturing sites, suppliers, and its Quality Compliance processes. The Quality oversight has to ensure the quality of our products, compliance with regulations, and that the products are developed, manufactured, and supplied in a timely manner, securing uninterrupted supply to internal and external customers. In addition, the role provides the management infrastructure and business processes which ensure that the right capabilities and capacity are in place to ensure quality compliant decisions, and inspection readiness is confirmed by successful authority inspections. The role also includes a responsibility for driving proactive quality risk management processes and mindset across the sites, fostering a culture of continuous improvement and risk based thinking. In addition, the incumbent is leading TEVA's offshoring centers for Stability Testing and PQR/APR Compilation. Location This role can be based in any Teva location in Europe. Travel 40 - 50% international travel expected. How you'll spend your day Lead the Site Quality Heads and their organizations in the manufacturing sites and ensures independent decision making related to product quality and Quality compliance aspects. Develop projects to simplify business processes in Quality in accordance with Teva's regulatory requirements and standards, driving the tools of the Teva Lean Management System and a proactive approach to risk management. Sponsor the execution of strategic compliance initiatives and remediation activities as applicable. Build and manage the appropriate infrastructure to manage and improve Quality relevant relations to external suppliers driving standardization and efficiencies. Ensure that Quality compliance is a critical parameter to secure supply for internal and external customers. Significantly influence strategy as it relates to the Quality function, local and global Quality compliance, Quality operations and Quality Relation management. Develop together with Quality Compliance strategic plans driving toward the achievement of company quality compliance, business and financial goals, monitored by key performing indicators and the adherence to well set targets and drive their execution. Support Operations strategic initiatives toward the achievement of the gross margin improvement program, through strong lean management approach across QA and QC (inc. Lean Labs in the QC operations), driven by a focus on proactive risk management and ICH principles. Ensures continuous improvement of the QMS at the sites. Foster the continuous improvement of the Quality culture in the organization. Lead an efficient Quality and manufacturing sites network, compliant with cGXP requirements of global regulatory agencies (FDA, EMA, ANVISA, MHRA, EAEU GMP, etc) and the Teva Quality Management System related to the development, manufacturing, packaging, testing, release and distribution of active pharmaceutical ingredients. Ensure the implementation and continuous improvement of the Teva Quality Management System at site level to ensure compliance with existing and evolving guidelines, to increase the efficiency of the quality processes and quality systems and to identify and execute corrective and preventive actions, where applicable to close gaps. Drive standardization and harmonization of best practices across the sites. Ensure sites inspection readiness, inspection management and in case of inspection observations, implementation of corrective and preventive actions in a timely manner meeting agencies expectation. Ensure that sufficient resources are made available. Ensure a strong deviation investigation management system is established and executed on site level, that identifies and investigates quality deviations to root cause, defines appropriate CAPAs, ensures CAPA effectiveness and timely reporting in accordance with regulatory requirements. Support direct handling and resolution of severe quality incidents. Foster the identification of best practices and state-of-the art technologies. Facilitate and monitor their implementation. Develop and lead optimization and efficiency processes. Ensure knowledge management across the network, share inspection / audit findings and knowledge to ensure timely site-based assessments and the identification of actions to prevent future or repeat findings. How you'll spend your day Oversee the Stability Testing, including: Performance of stability tests in TEVA's offshore-centers (Zagreb, Goa) with registered methods per yearly ongoing stability program (OGS) or after significant changes of the MA (ICH). Ensure that Product Robustness issues are addressed, and the root cause of Compliance issues are identified and remediated. Ensure that the necessary AMTs were performed successfully. Ensure that necessary method adoptions / re developments are initiated, if a certain analytical method is not stability indicating. Development and validation of stability indicating Methods as Service provider for TEVA sites or TPO. Storage and sampling of stability samples as per stability plan defined by the product owner (e.g. TEVA site). Coordination of testing, shipping and storage between the different TEVA Sites, EMSO suppliers and the Offshoring Centers. Identify Cost saving opportunities such as reduced testing, and use of Global Business Services (GBS), APRs/PQRs. Oversee the delivery of APR/PQRs by ensuring the planning, establishment, and management of work plans, required resources (headcount, expense, and capital) and expected capabilities to meet existing and future business needs. Ensure EHS&S mindset across the quality operations and laboratories in the cluster sites, and a proactive risk management approach to safety. Lead, mentor, and develop a high performing global team, promoting collaboration and innovation fostering a culture of accountability, professional growth, & employee engagement. Guides team members' professional growth and development and support selection of key quality resources. Your experience and qualifications Education/Qualifications Minimum of 15 years pharmaceutical manufacturing multiples sites quality operations and leadership experience. Direct interaction with health authorities. Experience working in a large, complex matrixed environment with global processes & governance structures; practical knowledge of pharmaceuticals manufacturing and/ or control. Practical knowledge of analytical techniques and microbiological principles practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering). Product and technology transfer. Critical Skills/Capabilities: Professional: Practical knowledge of Global Compliance and Regulatory requirements, Industry guidelines (e.g. ICH guidelines specifically M7, PIC/s, PDA), cGxP: Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice and other guidelines, the regulations of supervisory authorities at local and international level, specifically US FDA, EMA, etc. Practical knowledge in manufacturing, testing and health authority inspections and expectations for the dosage form in the site network. Ability to develop and execute Strategic / Long Range and Annual Business Plans Practical knowledge on risk management. OpEx and LMS. Essential: Strong critical thinking / problem solving skills to navigate ambiguous situations; Strategic thinking; Excellent storytelling and presentation skills; Cross functional collaboration and stakeholder management; Effective communication; Strong relationship and senior stakeholder management capabilities. Leadership: Strong leadership, change management & influencing skill ; Decision making under uncertainty skills; Ability to drive transformational change in a large/global/matrixed environment; Proven talent management & people development capabilities (incl. coaching and mentoring); Ability to create an engaging & inclusive work climate and a culture of appreciation and trust; Ability to set a vision and drive organizational change and innovation; Ability to manage effectively complexity within the organization (shifting timelines, projects, priorities). Already ? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority . click apply for full job details
Tevapharm
Runcorn, Cheshire
Select how often (in days) to receive an alert: Director Global OpEx Quality Ecosystems Lead Date: Feb 20, 2026 Location: Runcorn, United Kingdom, WA7 3FA Job Id: 66540 We Are Teva We're Teva, a leading innovative biopharmaceutical company, enabled by a world class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. The opportunity Teva Lean Management System (TLMS) is a Teva wide effort to design, implement, and sustain a lean production system, with an objective to reach world class manufacturing and supply performance across the network. The Global OpEx Quality Ecosystems Lead focuses on the design of production system components and their underlying detailed operating standards and maturity assessment for the QC & QA ecosystems. The incumbent will develop rapidly deployable, world class lean management system components, including but not limited to ensuring consistency and integration with other ecosystems, as well as overseeing the pilot of new components, refinement and ongoing Continuous improvement (CI) of TLMS operating standards. This requires the aggregation of inputs from multiple stakeholders; workshops will be used to evaluate current and external approaches and to align on an agreed model. The role will oversee piloting, refinement and ongoing CI of the design proposals and is critical for ensuring consistency and integration across other ecosystem designs. The role will be responsible for best practice identification & sharing across the network for the QC & QA Ecosystem. Location & Travel Preferred location; Haarlem (NL), co location in one of the TGO sites in Europe is possible. Travel is required, ability to travel - Up to 40% How you'll spend your day Aggregate inputs and address concerns from multiple stakeholders to reach true alignment on 'one best way'; Understand world class approaches and incorporate these opportunities into the design process while balancing the drive for excellence against practical solutions; Define long term state for the ecosystem and translate this into maturity phases requirements and corresponding maturity and phase assessments.; Own and drive the continuous improvement of ecosystem standards Ensure consistency and effective integration across ecosystems; partner with other Ecosystem leads to share and learn from best practices; Ensure that ecosystem designs are delivered on time and codified effectively; develop playbooks to support ecosystem deployment training. Deliver training at different organization levels; Align site and above site stakeholders to ensure designs are piloted, refined and improved effectively; ensure final designs are workable Build capabilities of site and when needed above site teams to leverage impact and value analysis to drive innovation and continuous improvement of Ecosystem standards while ensuring stability in the global design and deployment to sites; When applicable support TLMS Academy by supporting delivery of in person and virtual learning courses, as well as serve as a learning coach, and qualify practitioners against competency matrix; Conduct Maturity Assessments for the QC & QA Ecosystem, and potentially other ecosystems, providing feedback and supporting plans to improve maturity; Own a benchmarking on ecosystems level to identify and disseminate best practices supporting performance improvement. Convert best practices into relevant standards and drive standardization. Your experience and qualifications Bachelor degree in a Technical or Business field with 10+ years of relevant experience; Masters degree a plus with a minimum of 3+ years in a pharmaceutical quality role. Experience with design / installation and operation of world class production systems in a manufacturing environment. Specific experience in Quality (QC and/or QA) in one of the following areas in Pharma - Solids and/or Sterile drug Production, Packaging. Good understanding of BioPharma LMS (Lean Management Systems) e.g. iMEx, Integrated Work System (IWS) or similar production systems is a plus. Intellectual rigor and flexibility/tenacity to manage design trade offs; evidence of innovation, problem solving and structured thinking. Practicality to deliver workable solutions, capable of supporting processes from strategy to implementation. Strong presentation and facilitation skills. Excellent communication skills at various levels; demonstrated track record of leading and influencing organizations and/or teams. Proven capabilities in program management; success in executing projects with small & medium teams. Strong proficiency in Excel analytics and PowerPoint materials geared for senior site audiences; experience with SAP systems strongly preferred. Fluency in English required, other European language is preferred. How We'll Take Care of You At Teva, better health starts from within, and that includes you. From day one, you'll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you'll be encouraged to explore, evolve, and shape your path. Twist, our one stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short term projects to opportunities for internal growth. Here, you'll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. Already ? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Select how often (in days) to receive an alert: Director Global OpEx Quality Ecosystems Lead Date: Feb 20, 2026 Location: Runcorn, United Kingdom, WA7 3FA Job Id: 66540 We Are Teva We're Teva, a leading innovative biopharmaceutical company, enabled by a world class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. The opportunity Teva Lean Management System (TLMS) is a Teva wide effort to design, implement, and sustain a lean production system, with an objective to reach world class manufacturing and supply performance across the network. The Global OpEx Quality Ecosystems Lead focuses on the design of production system components and their underlying detailed operating standards and maturity assessment for the QC & QA ecosystems. The incumbent will develop rapidly deployable, world class lean management system components, including but not limited to ensuring consistency and integration with other ecosystems, as well as overseeing the pilot of new components, refinement and ongoing Continuous improvement (CI) of TLMS operating standards. This requires the aggregation of inputs from multiple stakeholders; workshops will be used to evaluate current and external approaches and to align on an agreed model. The role will oversee piloting, refinement and ongoing CI of the design proposals and is critical for ensuring consistency and integration across other ecosystem designs. The role will be responsible for best practice identification & sharing across the network for the QC & QA Ecosystem. Location & Travel Preferred location; Haarlem (NL), co location in one of the TGO sites in Europe is possible. Travel is required, ability to travel - Up to 40% How you'll spend your day Aggregate inputs and address concerns from multiple stakeholders to reach true alignment on 'one best way'; Understand world class approaches and incorporate these opportunities into the design process while balancing the drive for excellence against practical solutions; Define long term state for the ecosystem and translate this into maturity phases requirements and corresponding maturity and phase assessments.; Own and drive the continuous improvement of ecosystem standards Ensure consistency and effective integration across ecosystems; partner with other Ecosystem leads to share and learn from best practices; Ensure that ecosystem designs are delivered on time and codified effectively; develop playbooks to support ecosystem deployment training. Deliver training at different organization levels; Align site and above site stakeholders to ensure designs are piloted, refined and improved effectively; ensure final designs are workable Build capabilities of site and when needed above site teams to leverage impact and value analysis to drive innovation and continuous improvement of Ecosystem standards while ensuring stability in the global design and deployment to sites; When applicable support TLMS Academy by supporting delivery of in person and virtual learning courses, as well as serve as a learning coach, and qualify practitioners against competency matrix; Conduct Maturity Assessments for the QC & QA Ecosystem, and potentially other ecosystems, providing feedback and supporting plans to improve maturity; Own a benchmarking on ecosystems level to identify and disseminate best practices supporting performance improvement. Convert best practices into relevant standards and drive standardization. Your experience and qualifications Bachelor degree in a Technical or Business field with 10+ years of relevant experience; Masters degree a plus with a minimum of 3+ years in a pharmaceutical quality role. Experience with design / installation and operation of world class production systems in a manufacturing environment. Specific experience in Quality (QC and/or QA) in one of the following areas in Pharma - Solids and/or Sterile drug Production, Packaging. Good understanding of BioPharma LMS (Lean Management Systems) e.g. iMEx, Integrated Work System (IWS) or similar production systems is a plus. Intellectual rigor and flexibility/tenacity to manage design trade offs; evidence of innovation, problem solving and structured thinking. Practicality to deliver workable solutions, capable of supporting processes from strategy to implementation. Strong presentation and facilitation skills. Excellent communication skills at various levels; demonstrated track record of leading and influencing organizations and/or teams. Proven capabilities in program management; success in executing projects with small & medium teams. Strong proficiency in Excel analytics and PowerPoint materials geared for senior site audiences; experience with SAP systems strongly preferred. Fluency in English required, other European language is preferred. How We'll Take Care of You At Teva, better health starts from within, and that includes you. From day one, you'll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you'll be encouraged to explore, evolve, and shape your path. Twist, our one stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short term projects to opportunities for internal growth. Here, you'll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. Already ? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.