Senior QA Lead - GMP & Batch Release

Replimune-2; Abingdon; On-site; GBP 45,000 - 65,000; Full time

Job summary

Replimune is seeking a Quality Assurance Officer II to guide and coordinate the development, implementation and maintenance of QA systems at our Milton Park site. You will manage batch review for GMP lots and ensure timely release of drug products for clinical and commercial use, while maintaining MHRA, EMA, FDA and other guidelines.

You will work cross-functionally with QA, QC, Regulatory and Clinical teams to drive inspection readiness, lead change control, deviations and CAPA processes, and

Qualifications

• A bachelor's degree (BSc or equivalent) is required; master's preferred.
• ≥ 6 years of experience in Quality Systems in biotech/pharma.
• GxP experience, including auditing; knowledge of MHRA, EMA and FDA GMP guidelines.

Responsibilities

• Work cross-functionally with QA, QC, Regulatory and Clinical groups to ensure inspection readiness.
• Perform batch review for GMP lots in support of release including final QC documentation.
• Drive improvements in GMP compliance and Quality systems (CAPA, deviation, change control).
• Prepare and maintain quality records and reports with strong documentation skills.
• Report quality metrics for QMR deliverables and participate in audits.
• Review and approve SOPs, validation documents, and GMP records.

Skills

Excellent verbal and written commits

Attention to detail

Time management

Education

Bachelor's degree (BSc or equivalent)

Masters preferred

Tools

Microsoft Office

Job description

Replimune is seeking a Quality Assurance Officer II to guide and coordinate the development, implementation and maintenance of QA systems at our Milton Park site. You will manage batch review for GMP lots and ensure timely release of drug products for clinical and commercial use, while maintaining MHRA, EMA, FDA and other guidelines.

You will work cross-functionally with QA, QC, Regulatory and Clinical teams to drive inspection readiness, lead change control, deviations and CAPA processes, and