Quality Assurance Specialist – GMP & Compliance

Replimune; Abingdon; On-site; CAD 65,000 - 90,000; Full time

Job summary

Replimune is seeking a Quality Assurance Officer I to guide the development, implementation and maintenance of QA systems and to manage batch review for drug product releases. Based in Milton Park, this on-site role collaborates with QA, QC, Regulatory and Clinical teams to ensure inspection readiness and compliance with MHRA, EMA and FDA quality standards.

Applicants should have a bachelor’s degree (Masters preferred) and ≥4 years’ experience in regulated biotech/pharma, with GxP auditing and

Qualifications

• Bachelor’s degree required; Masters preferred.
• 4+ years in quality systems in regulated biotech/pharma.
• GxP experience including auditing.
• Knowledge of MHRA/EMA GMP guidelines.
• Strong written and verbal communication.

Responsibilities

• Work cross-functionally with QA, QC, Regulatory and Clinical groups to ensure inspection readiness.
• Perform batch review for GMP lots and support final Quality Review of quality records.
• Drive improvement of GMP compliance and quality systems (change control, deviation, CAPA).
• Lead training and develop SOPs, validation protocols/reports.
• Report quality metrics for QMR deliverables.
• Review and approve SOPs and GMP records.
• Interface with internal customers and external vendors to support compliance.
• Lead risk assessments and participate in audits.

Skills

Quality Systems

GxP Experience

Auditing

Regulatory Knowledge

Communication Skills

Time Management

MS Office

Education

Bachelor's degree

Master's degree preferred

Tools

Microsoft Office

Job description

Replimune is seeking a Quality Assurance Officer I to guide the development, implementation and maintenance of QA systems and to manage batch review for drug product releases. Based in Milton Park, this on-site role collaborates with QA, QC, Regulatory and Clinical teams to ensure inspection readiness and compliance with MHRA, EMA and FDA quality standards.

Applicants should have a bachelor’s degree (Masters preferred) and ≥4 years’ experience in regulated biotech/pharma, with GxP auditing and