Manager, Quality Assurance Operations
$118,000–$166,000 year
On-site · Somerville, Massachusetts, United States
Job Summary
The Manager, Quality Assurance Operations role provides end-to-end quality oversight of CMOs to ensure cGMP regulatory compliance and Genetix quality standards, serves as QA lead with external partners, drives Deviation and Change Control lifecycle management, and oversees APQRs, quality agreements, and governance forums; requires a Bachelor's degree in Life Sciences/Engineering and 7+ years of GMP QA experience in biopharmaceutical or cell/gene therapy manufacturing; skills include cGMP knowledge, CAPA, validation, and cross-functional leadership.
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, or related discipline
- 7+ years of experience in Quality Assurance within GMP-regulated biopharmaceutical or cell/gene therapy manufacturing
- Strong experience supporting CMO oversight and external manufacturing environments
- Deep knowledge of cGMP regulations (FDA, EMA, ICH guidelines), Deviation, CAPA, and investigation processes, Change Control systems and validation lifecycle
- Knowledge of lentiviral vector process preferred
- Knowledge of process validation preferred
- Strong understanding of cell/gene therapy manufacturing or biologics
- Demonstrated ability to lead cross-functional quality governance forums
- Excellent communication, stakeholder management, and influential skills in internal and external settings
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.