Quality Assurance Manager – Biopharma

About the role

Summit Therapeutics Inc. is seeking a Quality Assurance Manager to lead QA activities across its global oncology drug development programs. The role ensures compliance with EU GMP, regulatory requirements and internal standards, safeguarding product integrity and patient safety.

Key responsibilities

• Lead and manage quality assurance activities, including oversight of quality systems and batch release processes.
• Oversee remote batch release operations, providing real‑time quality oversight of manufacturing and testing performed by global CMOs and contract testing laboratories.
• Review and approve batch documentation using digital QMS platforms and electronic batch records (EBRs).
• Coordinate audits, drive continuous improvement initiatives and support product development and commercialization.
• Act as liaison between manufacturing, regulatory and quality teams to ensure alignment with company mission.

Required profile

• Proven experience in pharmaceutical quality assurance, preferably in oncology or biopharmaceutical environments.
• Strong knowledge of EU GMP regulations and regulatory compliance.
• Experience working with global contract manufacturing organizations and supply‑chain partners.
• Ability to manage documentation review and approval processes using digital systems.

Required skills

• EU GMP
• Digital QMS platforms
• Electronic batch records (EBR)