Associate Director, Country Head Quality Assurance - UK & Ireland page is loaded Associate Director, Country Head Quality Assurance - UK & Ireland Apply locations London - England Quality time type Full time posted on Posted 7 Days Ago job requisition id R17940 The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.
As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.
Moderna is solidifying its presence in London, a global hub for scientific research and innovation. Our London office focuses on commercial operations, ensuring the delivery of our revolutionary products to the UK market. We're seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.
This is a critical role for a seasoned pharmaceutical quality leader ready to shape Moderna's UK footprint. As Associate Director, Country Head, Quality - UK, you will hold dual responsibilities as the Responsible Person (RP/RPi) under EU GDP guidelines and as a Qualified Person (QP) under UK GMP standards. Your role will be pivotal in overseeing compliance, release operations, and quality assurance for Moderna's mRNA vaccine and pharmaceutical products across the UK. You will serve as the lead UK Quality representative, act as the key contact with the MHRA, and manage all national quality activities, ensuring GxP compliance across supply chain, distribution, storage, recall, and batch release. Working closely with global and local Quality teams, you will support regulatory filings, engage in continuous improvement of the Quality Management System, and contribute directly to the safe and effective delivery of Moderna's breakthrough products in the UK.
Here's What You'll Do
Responsibilities as RP/RPi
Undertake duties as Responsible Person on the wholesale Distribution License in compliance with EU Guidelines 2013/C 343/01 to include:
- Ensuring a QMS is implemented and maintained
- Focusing on the management of authorised activities and accuracy and quality of records
- Ensuring initial and continuous training programmes are implemented and maintained
- Coordination and promptly performing any recall operations for medicinal products
- Ensuring customer complaints are managed effectively
- Ensuring customers and suppliers are approved
- Approving any sub-contracted activities which may impact GDP
- Ensuring self-inspections are performed at regular intervals following a pre-arranged programme and necessary corrective actions are in place
- Keeping records of any delegated duties
- Deciding on the final disposition of returned, rejected, recalled or falsified product
- Approving any returns to saleable stock
- Ensuring additional requirements imposed on certain products by national law are adhered to
- Release of EU imported batches
Responsibilities as QP - Moderna UK Entities
- Execute QP responsibilities, duties, batch certification and disposition for products in the UK as defined in MHRA Guideline
- Execute responsibilities on behalf of Moderna UK License.
- Ensure products are manufacturing in accordance with cGMPs, internal policies/procedures and applicable regulatory requirements and guidance.
- Maintain thorough and up to date understanding of international regulatory requirements and guidance.
- Take actions necessary to maintain and extend technical and professional competence in support of QP responsibilities and ensure thorough understanding of any products and processes prior to conducting any QP batch certification and disposition.
- Understand and support review of investigations, root cause analysis and review and approval of major/critical deviations, complaints and change controls with process and product impact.
- Support Quality Systems and Compliance on continuous improvement of the Quality Management System (QMS), support quality management review processes, annual product quality reviews, overall inspection readiness and state of control.
- Establish and maintain effective communication with clients to match internal and external expectations.
- Interact with Health authorities as it pertains to Moderna's licenses and regulatory activities.
- Act as contact person for product defects and recalls for MHRA and any other applicable Health authority and support recall of product if needed.
- Provides QP GMP declarations in support of regulatory filings and assist in maintaining GMP/GDP regulatory licenses.
- Perform QP Audits internally and externally of suppliers and contract testing and contract manufacturing organizations and support health authority inspections.
- Ensure quality systems, processes, specifications, QAAs and SOPs are designed to be appropriate and applied for the development, manufacture, testing and timely release, and distribution of quality product, and consistent with the global quality strategy and meet all relevant regulatory requirements including local and international regulations and applicable standards and guidance's.
- Support review of international regulatory filing information to ensure data integrity and regulatory compliance.
Key Responsibilities and if appropriate Authorities of the Position:
- Serve as Company's Management Representative. Key contact with Governmental Quality contact to ensure appropriate distribution of vaccine in the national health system and resolution of any product quality issues reported
- Local Implementation and maintenance the company's quality system.
- Prepare the Quality Reviews and the monitoring of Quality related KPIs.
- Develop and administer department budgets, schedules, and other administrative functions.
- Create, update and ensure the thorough application of SOPs.
- Prepare internal and external audits, inspections, certifications and monitoring of associated CAPAs.
- Report to local Health Authorities any placing on the national market of a medicine which you consider to be falsified.
- Be responsible for all interactions with third party logistics provider(s), including the receipt and handling of goods into the warehouse.
- Complaint management, Deviation management, Risk analysis at local level.
- Manage pharmaceutical subcontractors: ensuring that the transportation conditions guarantee the appropriate conservation, integrity and security of the products.
- Implementation and monitoring of the distribution system (contracts, specifications, etc.)
- Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.
- Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
- Ensure Monitoring of medical samples if necessary
- Ensure implementation and monitoring of the distribution system (contracts, specifications, etc.)
- Ensure stock monitoring (stock forecast, authorization to distribute, declaration in the event of a risk or confirmed shortage, transport conditions, batch recall, returns, etc.)
- Comprehensive understanding of local Quality requirements, integration of them on the enterprise quality management system and a broad knowledge of Global quality functions.
The key Moderna Mindsets you'll need to succeed in the role:
- "We behave like owners. The solutions we're building go beyond any job description."
You will act as the primary Quality authority for Moderna in the UK, owning compliance responsibilities at every level-from audits and batch release to system-wide quality oversight-ensuring Moderna's integrity and performance in a critical market. - "We digitize everywhere possible using the power of code to maximize our impact on patients."
You will help identify and integrate digital solutions, including data integrity tools and generative AI-enhanced systems, to optimize compliance monitoring, documentation, and continuous improvement in Moderna's UK quality operations.
Here's What You'll Need (Basic Qualifications)
- Education: Minimum: Bachelor's Degree in relevant scientific discipline.
- QP Eligibility is a must
- Experience: Minimum: years significative experience within the pharmaceutical industry (quality, regulatory and pharmacovigilance area)
- Soft Skills: Influence others internally and/or externally, including other functions. Negotiation skills. Problem solving oriented.
- Demonstrated aptitude or ability to learn: . click apply for full job details