Quality Assurance Lead: GMP/CMC Oversight

BioSpace; Oxford (AL); On-site; USD 145,000 - 225,000; Full time

Job summary

Immunocore in Oxford, UK, is seeking an Associate Director, Quality Assurance to provide operational and leadership continuity across the medicinal product lifecycle, deputizing for the Director and guiding phase-appropriate, risk-based QA oversight of CMC, GMP, human tissue management and research operations.

As a SME within the Quality Unit, you will drive inspection readiness, QMS performance, and cross-functional quality oversight across manufacturing, supply chain, distribution and R&D

Qualifications

• Bachelor’s degree or higher in a relevant scientific discipline.
• 8+ years’ biopharmaceutical industry experience.
• Lead auditor to a recognized pharmaceutical standard.
• Extensive knowledge of CMC and GMP operations.
• QMS implementation and continuous improvement for GxP compliance.
• Experience manufacturing sterile injectable therapeutics.

Responsibilities

• Deputize for the Director, QA to ensure continuity of quality decisions across manufacturing, supply chain, distribution, and R&D.
• Act as quality advisor across the QA unit and wider organization.
• Develop and execute the Manufacturing Quality operating plan in line with enterprise strategy.
• Provide QA oversight for CMC and GMP operations across the product lifecycle, including outsourced QP services.
• Support PSF management and clinical supplies for IMPs.
• Oversee QA for commercial supply operations, including artwork management.
• Lead or support root cause analysis and CAPA for quality events.

Skills

Biopharma exp

Lead auditor

CMC GMP knowledge

QMS improvement

Cross-functional collab

Education

Bachelor’s degree in science

Lead auditor qualification

Tools

Microsoft Office

Job description

Immunocore in Oxford, UK, is seeking an Associate Director, Quality Assurance to provide operational and leadership continuity across the medicinal product lifecycle, deputizing for the Director and guiding phase-appropriate, risk-based QA oversight of CMC, GMP, human tissue management and research operations.

As a SME within the Quality Unit, you will drive inspection readiness, QMS performance, and cross-functional quality oversight across manufacturing, supply chain, distribution and R&D