Lead, Quality Assurance & GMP Compliance

Immunocore; Oxford; On-site; GBP 100,000 - 130,000; Full time

Job summary

Immunocore in Oxford, UK, is seeking a senior Quality Assurance leader to deputize for the Director of Quality Assurance. You will provide operational leadership across CMC, GMP, and research operations, ensuring phase-appropriate, risk-based quality oversight and inspection readiness throughout the medicinal product lifecycle.

As a SME in the Quality Unit, you will drive QMS performance, lead CAPA, oversee outsourced QA services, and collaborate across manufacturing, supply chain, distribution

Qualifications

• Essential: Bachelor’s degree or higher in a relevant scientific discipline.
• Essential: 8+ years’ experience in the biopharmaceutical industry.
• Qualified as a lead auditor to a recognized pharmaceutical standard.
• Extensive knowledge of CMC and GMP operations and QMS.

Responsibilities

• Provide operational and leadership continuity across QC/QA lifecycle.
• Deputize for the Director, Quality Assurance, and support risk-based quality oversight across CMC, GMP, and R&D interfaces.
• Drive inspection readiness, QMS performance, and cross-functional quality oversight.
• Lead risk-based decision-making, escalation of quality and regulatory risks, and cross-functional collaboration.
• Oversee quality governance for PSF management and clinical supplies for IMPs.
• Lead or support root cause analysis and CAPA for quality events.
• Contribute to regulatory submissions and RFIs with quality-relevant content.
• Represent the Quality Unit in internal and external meetings.

Skills

Lead auditor

CMC & GMP

QMS implementation

Cross-functional leadership

Regulatory inspections readiness

CAPA management

Root cause analysis

Data-driven decisions

MS Office proficiency

Education

Bachelor’s degree in a scientific discipline

8+ years biopharma experience

Job description

Immunocore in Oxford, UK, is seeking a senior Quality Assurance leader to deputize for the Director of Quality Assurance. You will provide operational leadership across CMC, GMP, and research operations, ensuring phase-appropriate, risk-based quality oversight and inspection readiness throughout the medicinal product lifecycle.

As a SME in the Quality Unit, you will drive QMS performance, lead CAPA, oversee outsourced QA services, and collaborate across manufacturing, supply chain, distribution