Senior Qualified Person - GMP Batch Release (Hybrid)

Replimune-2; Framingham Pigot; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

Replimune seeks a Qualified Person (QP) to certify batches in compliance with GMP and regulatory requirements across EU/UK. The role ensures batch release and product quality in alignment with marketing authorisation and clinical trial requirements.

Based at Milton Park with a 3-day on-site hybrid schedule. The QP will oversee all manufacturing and quality control activities, maintain robust pharmaceutical quality systems, and ensure traceability throughout the supply chain, with emphasis on

Qualifications

• Knowledge of EU/UK GMP guidelines
• Continuous professional development in regulatory affairs preferred
• Experience with batch release and certification processes

Responsibilities

• Ensure batch certification in compliance with GMP and regulatory requirements
• Oversee manufacturing and quality control activities per GMP principles
• Maintain records and traceability across manufacturing and distribution
• Lead batch review and disposition for EU/UK release
• Coordinate with manufacturing, QA and regulatory to support certification

Skills

GMP knowledge

Regulatory awareness

Quality systems

Education

B.A./B.S. in a scientific field

Tools

EU/UK GMP guidelines

Job description

Replimune seeks a Qualified Person (QP) to certify batches in compliance with GMP and regulatory requirements across EU/UK. The role ensures batch release and product quality in alignment with marketing authorisation and clinical trial requirements.

Based at Milton Park with a 3-day on-site hybrid schedule. The QP will oversee all manufacturing and quality control activities, maintain robust pharmaceutical quality systems, and ensure traceability throughout the supply chain, with emphasis on