Senior Qualified Person: GMP Compliance & Batch Release

Replimune; United Kingdom; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

The Qualified Person (QP) role at Replimune UK requires expertise in GMP compliance, with responsibilities covering batch release and release oversight across EU/UK jurisdictions. Based at Milton Park, the role typically requires on-site and hybrid work arrangements, and the candidate will ensure products meet all regulatory specifications and quality standards.

Eligible candidates should have a degree in a scientific field and at least two years in pharmaceutical quality assurance, with

Qualifications

• Knowledge of EU and UK regulations and guidelines regarding GMPs.
• Sufficient industry experience no less than two (2) years in relevant pharmaceutical fields.
• Experience with sterile products required and ATMPs preferred.

Responsibilities

• Certification of finished product batches to GMP and marketing/clinical trial authorisations.
• Lead batch review for EU and UK approvals and release.
• Oversee deviations, quality defects, change controls and complaints as appropriate.
• Ensure appropriate pharmaceutical quality systems are in place and maintained.

Skills

GMP regulations

ATMP experience

Sterile products

EU/UK regs

Education

Bachelor's degree in a relevant scientific field

M.S./Ph.D. encouraged

Job description

The Qualified Person (QP) role at Replimune UK requires expertise in GMP compliance, with responsibilities covering batch release and release oversight across EU/UK jurisdictions. Based at Milton Park, the role typically requires on-site and hybrid work arrangements, and the candidate will ensure products meet all regulatory specifications and quality standards.

Eligible candidates should have a degree in a scientific field and at least two years in pharmaceutical quality assurance, with