Associate Director, Country Head Quality Assurance - UK & Ireland

Joining Moderna offers the unique opportunity to be part of a pioneering team that is revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you will be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

This London-based role oversees Moderna’s pharmaceutical quality operations across the region and plays a key leadership role in delivering our UK commercial and government partnership commitments. As the Responsible Person (RP) and/or Responsible Person for Import (RPi) on the wholesale distribution license, you will ensure the company’s operations comply with all applicable GxP standards and EU GDP requirements. You will act as the primary quality interface with authorities, logistics partners, and internal stakeholders, while embedding Moderna’s enterprise quality vision at the local level.

Your key responsibilities will be:

• Serve as the Responsible Person (RP/RPi) under EU Guidelines 2013/C 343/01, ensuring QMS implementation and GDP compliance.
• Act as the Management Representative for the UK market, reporting on product quality and compliance.
• Lead the integration of quality functions for execution of UK government contracts and participation in the UK Quality Council.
• Oversee distribution system implementation (contracts, specifications, transport conditions, etc.) and ensure end-to-end product integrity.
• Ensure local implementation of Moderna’s global Quality System, aligning SOPs, CAPAs, KPIs, audits, and regulatory reporting.
• Maintain oversight of warehousing and third-party logistics providers, including complaints, deviations, and sample monitoring.
• Prepare for and manage inspections, certifications, and audit readiness across the UK & Ireland.

Your responsibilities will also include:

• Decision-making on returned, rejected, recalled, or falsified products, including batch disposition and approval of product returns.
• Management of customer complaints, training, internal self-inspections, and supplier qualification.
• Stock monitoring, including forecasting, risk declarations, authorizations to distribute, and handling of potential shortages.
• Maintain rigorous documentation and training compliance in accordance with Good Documentation Practices and Data Integrity principles.
• Ensure continuous improvement and cross-functional collaboration to promote a strong quality culture within the local affiliate.
• Lead and develop a high-performing quality team, fostering collaboration and compliance excellence.
• Integrate local regulatory requirements into the enterprise Quality Management System and liaise effectively with global Quality functions.

The key Moderna Mindsets you’ll need to succeed in the role:

• We behave like owners. The solutions we are building go beyond any job description: You will be the face of Quality for the UK & Ireland — ensuring Moderna’s standards and the public’s trust are upheld at every step.
• We digitize everywhere possible, using the power of code to maximize our impact on patients: From electronic quality systems to data tracking, your leadership will help digitize Moderna’s operations locally.

Here’s What You’ll Need (Basic Qualifications)

• Education: Minimum: Bachelor’s Degree in relevant scientific discipline.
• Experience: Minimum: +10 years significant 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: Able to gain a strong understanding of GxP regulations.

As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check. At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.