Medical Device Quality Manager jobs

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Main Purpose of Job:

Provide operational and leadership continuity across Immunocore's medicinal product lifecycle by deputizing for the Director, Quality Assurance, and supporting the delivery of phase-appropriate, risk-based Quality oversight across chemistry, manufacturing and controls (CMC), good manufacturing practice (GMP), human tissue management and research operations.

As a subject matter expert within the Quality Unit, apply deep technical knowledge to drive inspection readiness, QMS performance, and cross-functional quality oversight across internal and outsourced activities. Provide clear decision-making, appropriate escalation of quality and regulatory risks, and cross-functional collaboration across manufacturing, supply chain, distribution, and R&D interfaces.

Operate with a high degree of autonomy and independent judgment on complex quality matters, recommending best practices and identifying solutions to improve products, processes, and compliance outcomes across the organization.

Where applicable, this role will influence/impact wholesale distribution activities and therefore an understanding of the requirements of Good Distribution Practice as defined in Directive 2001/83/EC and various national legislation where Immunocore operates is essential.

Key Responsibilities:

• Deputize for the Director, Quality Assurance providing continuity of quality decision-making, risk escalation, and cross-functional leadership across manufacturing, supply chain, distribution, and R&D interfaces.
• Act as quality advisor and subject matter expert across the Quality Unit and wider organization, providing guidance on complex quality matters.
• Contribute to the development and execution of the Manufacturing Quality operating plan, including priorities and capability development, in alignment with enterprise Quality strategy.
• Provide quality oversight for CMC and GMP operations across the medicinal product life-cycle, including outsourced QP services, ensuring phase-appropriate compliance with applicable regulations, guidelines, standards, and internal quality processes.
• Support quality governance for Product Specification File (PSF) management and clinical supplies for investigational medicinal products (IMPs).
• Support quality oversight of commercial supply operations, including artwork management.
• Act as Quality lead, or support as required, for critical product quality events, ensuring effective decision-making, communication, and timely execution of containment and remediation actions.
• Support quality oversight of human tissue management operations, ensuring compliance with applicable international standards and ethical requirements.
• Contribute to Immunocore's regulatory inspection readiness program, ensuring quality systems, documentation, and processes are inspection-ready at all times.
• Monitor and analyze QMS KPIs and metrics, identify trends, emerging risks, and systemic opportunities for improvement, and report or escalate findings appropriately.
• Lead or contribute to root cause analysis and CAPA management for quality events, driving timely and effective resolution.
• Identify and recommend best practices or new solutions to improve processes, and/or compliance outcomes across the organization.
• Contribute to regulatory submissions, filings, and responses to regulatory information requests (RFIs), ensuring quality-relevant content is accurate and consistent.
• Partner cross-functionally to ensure effective quality oversight and alignment on shared objectives.
• Proactively engage key stakeholders across the business on complex and unique quality matters.
• Represent the Quality Unit at internal and external meetings, including cross-functional forums, as required.
• Contribute to quality management review processes, providing data-driven input on performance, risks, and improvement opportunities.

Education, Experience and Knowledge:

Essential Qualifications:

• A Bachelor's degree or higher qualification in a relevant scientific discipline
• At least 8 years' relevant experience in the biopharmaceutical industry
• Qualified as a lead auditor to a recognized pharmaceutical industry standard
• Extensive knowledge and experience in:

o CMC and GMP operations
o QMS - implementation, management and continuous improvement to ensure GxP compliance with regulatory requirements
o Manufacture of sterile injectable therapeutics produced through microbial and/or mammalian biopharmaceutical processes
(advantageous: experience in T-cell antigen receptor-based therapeutics)
o Drug development

• Ability to collaborate across multiple functions and business areas, aligning diverse teams to deliver Quality and business objectives
• Proven ability to influence, negotiate and engage diverse stakeholders, to drive quality decisions and outcomes
• Advanced written, verbal and cross-functional communication skills
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).

Preferred Qualifications:

• Experience of working in clinical research
• Knowledge of clinical trials processes.