QA Compliance & Batch Release Specialist

Replimune; Abingdon; On-site; GBP 55,000 - 75,000; Full time

Job summary

Replimune is seeking a Quality Assurance Officer I to guide and coordinate QA systems for drug product release at our Milton Park site. The role ensures GMP compliance and regulatory alignment with MHRA, EMA, and FDA requirements, with a 5-day on-site expectation.

You will work cross-functionally to support batch release, CAPA, deviations, and quality metrics, contributing to a robust QA program across vendors and internal teams.

Qualifications

• Bachelor’s degree (BSc or equivalent); Masters preferred.
• ≥4 years’ experience in quality systems, supervision in a regulated biotech/pharma environment.
• GxP experience, including auditing.
• Knowledge of MHRA, EMA and GMP guidelines.
• Excellent verbal and written communication skills.
• High level of attention to detail and strong time management.
• IT skills – Microsoft Office.
• Flexibility to varying workloads.

Responsibilities

• Work cross functionally with QA, QC, Regulatory and Clinical groups to ensure inspection readiness.
• Perform GMP batch review for release and final QA review of quality records.
• Drive improvement of GMP compliance and quality systems (change control, deviation, CAPA).
• Possess strong writing skills to document deviations and reports.
• Collect and report quality metrics for QMR deliverables.
• Review SOPs, validation protocols/reports, GMP records and related documents.
• Interface with internal customers and external vendors to support compliance.
• Lead risk assessments and conduct trainings.
• Conduct routine compliance oversight activities and audits.

Skills

GxP experience

Auditing

Quality systems

Regulatory knowledge

Communication

Attention to detail

Time management

MS Office

Education

Bachelor's degree or equivalent

Masters preferred

Job description

Replimune is seeking a Quality Assurance Officer I to guide and coordinate QA systems for drug product release at our Milton Park site. The role ensures GMP compliance and regulatory alignment with MHRA, EMA, and FDA requirements, with a 5-day on-site expectation.

You will work cross-functionally to support batch release, CAPA, deviations, and quality metrics, contributing to a robust QA program across vendors and internal teams.