Senior Qualified Person - EU/UK GMP & Batch Release

Replimune; Framingham (MA); Hybrid; USD 94,000 - 148,000; Full time

Job summary

Replimune Group, Inc., based in Woburn, MA, is seeking a Qualified Person (QP) to certify batches for EU/UK markets, ensuring GMP compliance and alignment with marketing authorisations. The role emphasizes heavy involvement in the full supply chain, batch records, and regulatory documentation.

The successful candidate will have a scientific degree and at least two years in pharmaceutical manufacturing, sterile products experience, and knowledge of EU/UK GMP guidelines, with ATMP experience

Qualifications

• Eligible as Qualified Person per Article 49 of 2001/83/EC.
• Knowledge of EU/UK GMP regulations and guidelines.
• Minimum 2 years in relevant pharmaceutical fields.
• Experience with sterile products; ATMP preferred.

Responsibilities

• Certify batches for release under GMP and regulatory standards.
• Maintain quality systems and compliance across the supply chain.
• Oversee batch review and disposition for EU/UK products.
• Collaborate with manufacturing sites and external audits.

Skills

GMP knowledge

Regulatory knowledge EU/UK

ATMP experience

Education

Bachelor's degree in a scientific field

Job description

Replimune Group, Inc., based in Woburn, MA, is seeking a Qualified Person (QP) to certify batches for EU/UK markets, ensuring GMP compliance and alignment with marketing authorisations. The role emphasizes heavy involvement in the full supply chain, batch records, and regulatory documentation.

The successful candidate will have a scientific degree and at least two years in pharmaceutical manufacturing, sterile products experience, and knowledge of EU/UK GMP guidelines, with ATMP experience