Senior QA Operations & GMP Compliance Specialist

Replimune Group; Framingham (MA); On-site; USD 134,000 - 173,500; Full time

Job summary

Replimune Group, Inc. in Framingham, MA seeks a Principal Associate I/II, Quality Assurance to support GMP compliance and product disposition for BDS, DP, and FDP across internal and external facilities.

You will collaborate with QA, QC, Regulatory, and Clinical teams, manage batch release, investigations, CAPAs, and quality events, and mentor QA staff to ensure continuous supply of investigational and commercial products under GxP guidelines.

Qualifications

• Minimum 6+ years in GCP, GMP, and QA/Compliance in pharma/biologics.
• Experience with quality systems and GxP within regulated environments.
• Hands-on batch release, investigations, deviations, CAPA.
• Knowledge of US FDA/EU GMP, ICH guidelines.
• Experience with audits and vendor/CMO interactions.
• Proficient with Master Control, Veeva or eQMS systems.

Responsibilities

• Support GMP compliance for bulk drug substance and drug product.
• Coordinate internal/external batch release and COAs.
• Manage product complaints and disposition reviews.
• Review packaging master records for investigational products.
• Approve finished products for shipment with QA sign-off.
• Lead root-cause analyses and CAPA activities.
• Mentor QA staff and support internal/external audits.
• Collaborate cross-functionally with QA, Regulatory, and Clinical teams.

Skills

GxP Knowledge

GMP

Quality Assurance

Regulatory compliance

Audit readiness

Documentation

Communication

Attention to detail

Project coordination

Education

Bachelor degree in chemistry, biology, biochemistry or microbiology

MSc or PhD preferred

Tools

Master Control

Veeva

eQMS

Excel

PowerPoint

Word

SmartSheets

Job description

Replimune Group, Inc. in Framingham, MA seeks a Principal Associate I/II, Quality Assurance to support GMP compliance and product disposition for BDS, DP, and FDP across internal and external facilities.

You will collaborate with QA, QC, Regulatory, and Clinical teams, manage batch release, investigations, CAPAs, and quality events, and mentor QA staff to ensure continuous supply of investigational and commercial products under GxP guidelines.