Principal Associate II, Quality Assurance Operations
$134,000–$134,000 year
On-siteFramingham, Massachusetts, United States
Job Summary
Manage internal and external batch release for GMP lots, coordinating disposition, Certificate of Analysis issuance, and packaging approvals for investigational and commercial products. Work cross-functionally with Quality, Regulatory, and Clinical teams to ensure inspection readiness, verify batch compliance with 21 CFR 210/211, and oversee product complaints. Drive GMP compliance improvements through root cause analysis, CAPA support, and deviation management while leading batch release audits as a Subject Matter Expert. Provide training to QA personnel and communicate performance metrics to leadership. Based in Framingham with a 5-day on-site expectation, this role supports Replimune's mission to revolutionize cancer treatment through rigorous quality assurance operations.
Required Qualifications
- Bachelor degree in appropriate Science (chemistry, biology, biochemistry, microbiology)
- Minimum 6+ years of experience in GCP, GMP, and Quality Assurance/Compliance in the pharmaceutical, biopharma/biologics industry performing direct hands-on work in Quality Assurance, Quality Control, laboratories, manufacturing, supply chain, facilities, or engineering
- A working knowledge of GxP practices, US FDA and EU GMP regulations and ICH guidelines
- Demonstrated knowledge and direct experience with Quality Systems and GxP compliance within a regulated environment
- Experience managing product complaints
- Experience managing quality events (i.e. Deviations, CAPA)
- Experience with Master Control, Veeva or eQMS systems
- Excel, PowerPoint, Word, SmartSheets proficient
- Experience revising procedures and documents
- Excellent attention to detail
- Excellent verbal and written communication and presentation skills across all levels
- Prioritize and manage multiple priorities and projects with little assistance
- Familiarity with clinical and commercial supply areas and processes
- This position is based in our Framingham location and typically has a 5-day on-site expectation
Desired Qualifications
- MSc or PhD
- Experience managing product complaints is preferred
- Experience managing quality events (i.e. Deviations, CAPA)
- Experience with Master Control, Veeva or eQMS systems preferred
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