What are the responsibilities and job description for the Quality Assurance Operations Manager position at JCW Group?
JCW Is partnering with a growing cell therapy manufacturing organization seeking a QA Operations Manager to lead floor-based quality oversight in a cGMP environment. This is an on-site position in NC.
Key Responsibilities:
- Lead and develop QA OTF team; ensure training and readiness
- Provide real-time QA support on the manufacturing floor
- Review batch records and GMP documentation
- Make quality decisions (line clearance, room/equipment release, deviations)
- Identify/escalate GMP issues and support investigations
- Partner cross-functionally to maintain compliance and operational control
Requirements:
- Bachelor’s in a scientific field
- 5 years QA experience in cGMP aseptic/sterile manufacturing
- Strong knowledge of FDA/EU/ICH regulations
- Proven leadership and ability to work in fast-paced environments