Overview
Joining Moderna offers the unique opportunity to be part of a pioneering team revolutionizing medicine through mRNA technology, with a diverse pipeline across various diseases. You will be part of a growing organization, working with exceptional colleagues and strategic partners worldwide to contribute to global health initiatives. Moderna is expanding its presence in London to focus on commercial operations and delivering our products to the UK market. We are seeking talents ready to contribute to our mission and transform health worldwide.
This is a critical role for a seasoned pharmaceutical quality leader; 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. You will oversee compliance, release operations, and quality assurance for Moderna’s mRNA vaccine and pharmaceutical products across the UK, 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 the supply chain, distribution, storage, recall, and batch release. You will collaborate with global and local Quality teams to support regulatory filings and continuously improve the Quality Management System to ensure safe and effective delivery in the UK.
Responsibilities
Responsibilities as RP/RPi
Undertake duties as Responsible Person on the wholesale Distribution License in compliance with EU Guidelines 2013/C 343/01, including:
* Ensure a QMS is implemented and maintained
* Manage authorised activities and maintain records for accuracy and quality
* Implement and maintain initial and continuous training programs
* Coordinate and perform recall operations for medicinal products
* Manage customer complaints effectively
* Approve customers and suppliers
* Approve sub-contracted activities impacting GDP
* Perform regular self-inspections with corrective actions
* Keep records of delegated duties
* Decide final disposition of returned, rejected, recalled or falsified products
* Approve returns to saleable stock
* Adhere to additional national product requirements
* Release EU imported batches
Responsibilities as QP – Moderna UK Entities
* Execute QP responsibilities, duties, batch certification and disposition for UK products as defined in MHRA guidelines
* Act on behalf of Moderna UK License
* Ensure products are manufactured in accordance with cGMPs and applicable requirements
* Maintain understanding of international regulatory requirements and guidance
* Maintain technical and professional competence for QP responsibilities
* Support review of investigations, root cause analysis, deviations, complaints and change controls with process and product impact
* Support continuous improvement of the QMS, quality management reviews, and inspection readiness
* Establish and maintain effective communication with clients to align expectations
* Interact with Health authorities for licenses and regulatory activities
* Serve as contact for product defects and recalls for MHRA and other authorities
* Provide QP GMP declarations for regulatory filings and assist in maintaining GMP/GDP licenses
* Perform QP audits of suppliers and contract organizations and support health authority inspections
* Ensure quality systems and SOPs are aligned with global strategy and regulatory requirements
* Support international regulatory filing reviews for data integrity and compliance
Key Responsibilities and Authorities
* Serve as Company’s Management Representative and primary quality contact for vaccine distribution in the national health system
* Implement and maintain the company’s quality system locally
* Prepare Quality Reviews and monitor quality KPIs
* Develop and administer department budgets, schedules, and administrative functions
* Create, update and enforce SOPs
* Prepare audits, inspections, certifications, and CAPA monitoring
* Report falsified medicines to Health Authorities
* Manage relationships with third-party logistics providers and warehouse operations
* Handle complaint management, deviation management, and local risk analysis
* Manage pharmaceutical subcontractors and ensure appropriate distribution conditions
* Implement and monitor the distribution system and related contracts
* Foster a positive, collaborative, and continuously improving culture
* Follow GxP regulations, guidelines, and company policies
* Execute tasks as defined in SOPs and work instructions
* Maintain Good Documentation and Data Integrity in records and supports audits
* Complete required training and requalification
* Monitor medical samples if necessary
* Oversee distribution system monitoring and stock management including forecasts, approvals, shortages, recalls and returns
* Maintain comprehensive understanding of local quality requirements within the global quality framework
The Moderna Mindsets
* We behave like owners. 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.
* We digitize everywhere possible using the power of code. You will identify and integrate digital solutions to optimize compliance monitoring, documentation, and continuous improvement in UK quality operations.
Basic Qualifications
* Education: Minimum: Bachelor’s degree in a relevant scientific discipline
* QP Eligibility: Required
* Experience: Minimum 10 years in pharmaceutical quality, regulatory or pharmacovigilance
* Soft Skills: Ability to influence others, negotiation, problem-solving
* Demonstrated aptitude: Ability to learn and apply GxP regulations
Benefits
* Quality healthcare and insurance benefits
* Lifestyle Spending Accounts and well-being programs
* Free access to fitness, nutrition, and mindfulness resources
* Family planning and adoption benefits
* Generous paid time off and flexible leave options
* Savings and investments
* Location-specific perks
The benefits offered may vary by country.
About Moderna
Since 2010, Moderna has aspired to build the leading mRNA technology platform and infrastructure to reimagine how medicines are created and delivered. We value belonging, patient focus, and innovation. We have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
Moderna supports an in-person culture with a 70/30 in-office model to foster collaboration, mentorship, and innovation.
If you want to make a difference and join a team changing the future of medicine, visit the careers page at modernatx.com/careers to learn about current opportunities.
Moderna is a smoke-free, alcohol-free, and drug-free work environment. Moderna is committed to equal opportunity and non-discrimination for all employees and applicants. We welcome qualified applicants regardless of race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military status, genetic information, sexual orientation, marital status, or any other protected characteristic. We also provide accommodations for applicants with disabilities; contact the Accommodations team at leavesandaccommodations@modernatx.com.
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