bioM?rieux BV

Job Description Permanent contract is possible Associate Director/ESQL Purpose of the role You are responsible for implementing Quality Operations (QA/QC) policies and ensuring compliance with external partners (EPs) involved in the manufacturing, testing, packaging, storage, and distribution of API and intermediates. You ensure that all products are manufactured using approved processes and meet regulatory and company standards, potentially including product release. You play a leadership role in monitoring compliance with GMP, ICH, FDA, and other regulatory requirements. Responsibilities include direct oversight of external partners, providing technical guidance to senior site leadership, and supporting partner selection, GMP due diligence, and Quality Agreement setup. You also support building robust quality systems and driving continuous improvement initiatives at partner sites. Main responsibilities Ensures the EP's Quality Operations comply with company policies and global GMP/regulatory requirements. Develops and maintains Quality Agreements with external partners and contributes to commercial contract terms related to quality. Implements a calibrated quality oversight program, based on product type, EP capabilities, and compliance performance. Responsible for product release (e.g., API intermediates), ensuring conformance to specifications, approved processes, and regulatory requirements. Provides direct QA/QC support to EPs, including oversight of product testing, batch documentation review, and deviation investigations. Maintains and oversees supplier performance management, including regulatory inspections, complaint handling, feedback, and annual product reviews. Reviews audit outcomes and ensure timely corrective and preventive actions at EP sites. Monitors and drives continuous improvement in EP quality and reliability through regular oversight and formal communication forums. Supports new product introductions, including compliance input, analytical/process implementation, and inspection readiness. Prepares and supports content for Quality Council meetings, including minutes and presentations. Coordinates or supports significant investigations (e.g., Fact Findings) and product recalls. Ensure compliance with corporate Safety and Health Policy in all activities. Conducts due diligence and pre-approval assessments for new external partners and supports gap remediation. May act as regulatory liaison with authorities on behalf of the company regarding external partner activities. Collaborates cross-functionally to align EP oversight with broader business and operational objectives. Your profile Bachelor's or master's degree in science, Engineering, or another relevant technical discipline (e.g. Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent). Prior experience in the pharmaceutical industry. Thorough knowledge of Quality Systems, Quality Assurance, and Quality Control. Solid understanding of global GMP standards and regulatory compliance requirements. Prior experience in API manufacturing and/or external manufacturing support (preferred). Experience managing and supporting Quality Operations involving external parties (e.g. contract manufacturers, testing labs, distribution partners). Strong analytical and scientific problem-solving skills, with ability to assess complex product, production, or testing issues. Broad knowledge of manufacturing operations, external supplier management, and supply chain processes and project management. Conversant with regulations and compendia governing pharmaceutical operations. Some levels of contractual and financial awareness. Demonstrated ability to work independently, with guidance required only in highly complex situations. Proactive in internal or external business and compliance issues identifying and recommending process or product improvements. Strong verbal and written communication skills in English. Demonstrated personal networking and relationship-building skills. Ability to make sound decisions in an ambiguous or rapidly changing environment. Lean Six Sigma or continuous improvement experience (preferred). Willingness and ability to travel up to 25% of the time, including on short notice. What we offer We welcome you to a truly global, dynamic, and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect. Competitive salary and a 3% year-end bonus. 35,5 days of leave. Attractive collective health care insurance package. Solid Pension Plan. Incentive Plan (bonus). Commuting allowance. Parental leave for both parents. Numerous training, coaching, and e-learning modules for long term job opportunities and development. Secondary Job Description Who We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. Search Firm Representatives Please Read Carefully Organon LLC , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Annualized Salary Range Annualized Salary Range (Global) Annualized Salary Range (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites 25% Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1 Requisition ID:R534462

Job Description Organon is recruiting for an Operations Project Manager to join our world class manufacturing site in Cramlington, Northumberland. In the role, you will be responsible for planning, oversight and leading operations/site-based projects from idea through to completion. This role that requires interaction with a range of internal and external stakeholders and completing complex projects which impact multiple departments. Role Responsibilities Driving project management expertise and standardisation. Increasing capability in others for project management, promoting best practice and ensuring standards are met. Work with key stakeholders across the business to develop project execution plans that are fully scoped with clear success criteria, meet the business requirement, are accurately costed and are supported by realistic schedules and resource plans. Delivery of approved projects with a strong focus on project controls. Detailed tracking of items through to completion of first commercial batches produced. Conducting project review and creating senior leaders updates. Optimising and improving processes and the overall approach where necessary. Skills, Qualifications & Experience Demonstrable experience working in Pharma, FMCG or highly regulated industry. Degree in a Science or Engineering related subject or equivalent work experience. Worked with multiple departments/stakeholders across the business. Understanding of end-to-end business processes. Understanding of downstream and upstream impact within the process. Project management expertise (willingness to complete project management training). Ability to multi-task and manage various project elements simultaneously. Secondary Job Description Who We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. Search Firm Representatives Please Read Carefully Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Annualized Salary Range Annualized Salary Range (Global) Annualized Salary Range (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country. Employee Status Regular Relocation: No relocation VISA Sponsorship Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites Shift Flexible Work Arrangements: Valid Driving License Hazardous Material(s): Number Of Openings 1 Requisition ID: R535233

Job Description Organon is hiring a Senior HR Business Partner (HRBP) to join our manufacturing site in Cramlington , Northumberland . This role places a strong emphasis on employee and labour relations. The Senior HRBP will be the primary advisor on complex employee matters, while also supporting organisational change and talent development. The role is pivotal in driving people strategies that align with business goals, fostering a culture of inclusion, and enabling leadership effectiveness. This position is a 24-month fixed-term contract. Role Responsibilities: Lead employee and labour relations across the site, ensuring alignment with UK employment law and company policies. Provide proactive guidance to managers on complex cases including performance management, investigations, disciplinary actions, and potential tribunals. Promote a preventative approach by educating leaders on company values, behaviours, and legal considerations. Coach leadership teams through key people processes such as performance reviews, succession planning, and reward cycles, identifying and addressing capability gaps. Support talent acquisition efforts in collaboration with Global Talent Acquisition (GTA), contributing to strategic hiring initiatives. Utilise HR systems and data analytics to support informed decision-making and improve workforce planning. Lead or contribute to strategic HR initiatives and change programmes, working with global HR and cross-functional teams to implement sustainable solutions. Support 350-400 employees and partner with 30-40 leaders across Manufacturing, Global Functions, and Matrix structures, with a strong focus on employee relations expertise . Required Education, Experience and Skills : Extensive experience in employee and labour relations, including managing complex cases from performance improvement to tribunal . Strong knowledge of UK employment law and its practical application in a manufacturing environment . Proven ability to coach managers through sensitive employee issues with legal and ethical integrity . Strong HR expertise across multiple disciplines, including organisational development and change management . Proven ability to influence and coach first-line, middle, and occasionally senior leaders . Skilled in navigating ambiguity and balancing business needs with legal and ethical standards . Excellent communication and interpersonal skills, with the ability to build trust and credibility . Strategic mindset with the ability to prioritise high-impact initiatives . Proficient in HR systems and data analysis to support evidence-based decision-making . Strong negotiation skills, particularly in conflict resolution and legal matters . Preferred Education, Experience and Skills : Previous HR Business Partner experience in a manufacturing and matrixed environment. In-depth knowledge of UK employment law and HR best practices. Demonstrated success in managing complex employee relations cases Secondary Job Description Who We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. Search Firm Representatives Please Read Carefully Organon LLC , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Annualized Salary Range Annualized Salary Range (Global) Annualized Salary Range (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country. Employee Status: Temporary (Fixed Term) Relocation: No relocation VISA Sponsorship: Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1 Requisition ID:R535344

Job Description Organon is looking for a highly skilled Regional Europe Total Reward Partner to join our dynamic HR team. This role requires a strategic thinker with strong analytical abilities and excellent communication skills to develop and implement total reward strategies across our European operations and collaborate on global initiatives. Preferred location for this role is the UK, but Switzerland is also an option. Role Responsibilities: Strategic Planning: Develop and execute total reward strategies that align with business objectives and enhance employee engagement. Compensation Analysis: Conduct detailed market analysis and benchmarking to ensure competitive and equitable compensation structures. Benefits Management: Design and manage comprehensive benefits programs, including health insurance, retirement plans, and wellness initiatives. Broker and Insurer Management: Oversee relationships with brokers and insurers to ensure optimal service delivery and cost-effectiveness. Regulatory Compliance: Ensure all reward programs comply with local labor laws and company policies and governance. Stakeholder Collaboration: Partner with HR Business Partners, Finance, and senior leadership to align reward strategies with organizational goals. Data-Driven Decision Making: Utilize data analytics to assess the effectiveness of reward programs and recommend improvements. Project Leadership: Lead and/or participate in Global/Regional HR projects related to total reward and employee engagement. Required Education, Experience, and Skills Analytical Skills: Strong ability to analyze data, conduct market research, and interpret complex information to make informed decisions. Communication Skills: Excellent verbal and written communication skills to effectively convey reward strategies and policies to employees and stakeholders. Strategic Thinking: Ability to think strategically and develop long-term plans that align with business goals. Technical Proficiency: Proficiency in HRIS and compensation software, with the ability to leverage technology for data analysis and program management. Regulatory Knowledge: In-depth understanding of European labor laws and regulations related to compensation and benefits. Project Management: Strong project management skills to lead and execute HR initiatives effectively. Collaboration: Ability to work collaboratively with cross-functional teams and build strong relationships with stakeholders. Bachelor's degree in Human Resources, Business Administration, or a related field. Master's degree or relevant certification (e.g., CCP, GRP, CIPD) is a plus. Minimum of 5-10 years of experience in compensation and benefits, with a focus on European markets.