Associate Director, Quality Assurance

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.

Vacancy Name
Associate Director, Quality Assurance
Vacancy No
VN861

Employment Type

Full Time
Location of role
Oxford, UK
Department
Clinical QA

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 judgement 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.

• 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 lifecycle, 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 elevate 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.
• Con…