Senior QA Operations Specialist

Replimune-2; Framingham (MA); On-site; USD 134,000 - 173,500; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid holidays

Paid time off

Job summary

Replimune in Framingham, MA seeks a Principal Associate I/II, Quality Assurance to support GMP compliance for bulk drug substance, drug product and final drug product, including CMO/3PL interfaces. The role requires deep GxP knowledge, strong communication, and ability to work cross-functionally to ensure continuous supply of investigational and commercial products.

The candidate will oversee batch release, product complaints, CAPA, change control, deviations, and QA metrics, while mentoring QA

Qualifications

• Minimum 6+ years of experience in GCP, GMP, and Quality Assurance/Compliance in pharma/biopharma/biologics.
• Experience with QA/Compliance in regulated environments including manufacturing and laboratories.
• Familiarity with FDA/EU GMP regulations and ICH guidelines.

Responsibilities

• Coordinate batch release and disposition for GMP lots.
• Review testing records and investigations to ensure compliance.
• Lead CAPA, deviations and investigations with root cause analysis.
• Support internal/external batch release audits as SME.
• Mentor QA personnel and develop training.

Skills

GxP compliance

GMP regulations

Quality Assurance

Documentation

Excel/Office tools

Risk assessment

Regulatory knowledge

Root cause analysis

Education

Bachelor’s degree in chemistry/biology/microbiology/biochemistry

MSc or PhD preferred

Tools

Master Control

Veeva

eQMS

Job description

Replimune in Framingham, MA seeks a Principal Associate I/II, Quality Assurance to support GMP compliance for bulk drug substance, drug product and final drug product, including CMO/3PL interfaces. The role requires deep GxP knowledge, strong communication, and ability to work cross-functionally to ensure continuous supply of investigational and commercial products.

The candidate will oversee batch release, product complaints, CAPA, change control, deviations, and QA metrics, while mentoring QA