QA Manager – CMC/GMP Oversight (12‑Month Contract, Oxford)

Immunocore; Oxford; Sur place; GBP 65 000 - 90 000; Plein temps

Résumé du poste

Immunocore in Oxford, UK is seeking a QA Manager to provide quality oversight of CMC/GMP operations for investigational and licensed products, working within the GxP QMS and collaborating with internal teams and external partners.

The role involves deviations, CAPA, supplier quality, audits, and continuous improvement, with a focus on GDP awareness and regulatory compliance; it is a 12-month contract and requires strong auditing and QA leadership.

Qualifications

• Essential: Bachelor’s degree in a relevant scientific subject.
• Trained and/or certified as an auditor to an internationally recognized standard.
• 5 years’ experience in the Quality unit within life sciences/pharmaceutical industry.
• Practical experience with QMS and regulatory standards.
• Knowledge of CMC lifecycle quality oversight and GMP.
• Experience collaborating with stakeholders and leading QA activities.

Responsabilités

• Provide quality oversight for CMC and GMP operations and ensure regulatory compliance.
• Manage the Product Specification File (PSF) for IMP.
• Oversee commercial artwork management and validation activities.
• Lead/support QMS components: document management, deviations, change controls, supplier quality management.
• Conduct internal audits as lead/support auditor and supplier audits per schedule.
• Support training and knowledge of regulatory requirements.

Connaissances

Auditing

Quality oversight

Regulatory knowledge

Communication skills

Formation

Bachelor's degree in life sciences

Auditor certification

Description du poste

Immunocore in Oxford, UK is seeking a QA Manager to provide quality oversight of CMC/GMP operations for investigational and licensed products, working within the GxP QMS and collaborating with internal teams and external partners.

The role involves deviations, CAPA, supplier quality, audits, and continuous improvement, with a focus on GDP awareness and regulatory compliance; it is a 12-month contract and requires strong auditing and QA leadership.