Senior Quality Assurance Manager
In this capacity, you will be responsible for managing QA activities relating to drug product and clinical trial material release. You will review fill finish, packaging, and labeling batch records, manage deviation investigations, change controls, non-conforming events and manage relationships with contract manufacturing organizations (CMO’s). You will conduct external audits of CMO’s to ensure compliance with FDA and EU regulations. Travel in this position is approximately 20% (domestic and international).
At minimum, you must possess a Bachelor’s degree with 5+ years of QA pharmaceutical/biotechnology industry experience in GMP regulated commercial environment, people management experience, and drug product experience. External auditing experience and CMO management experience is also required.
Apply now for consideration.
Summary
- Job type:
- Full Time
- Industry
- Pharmaceuticals
- Location
- Maryland
- Specialism
- Pharma
- Pay
- Competitive / Based on Experience
- Ref:
- 1092847
Talk to a consultant
Talk to Phu Huynh, the specialist consultant managing this position, located in New York
23rd Floor, 555 Eighth Avenue, New York, NY, United States of America, 10018-4378