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Associate Director, Quality Control Compliance
Job in
Hopewell, Mercer County, New Jersey, 08525, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist
Job Description & How to Apply Below
overseeing GMP lab compliance for large and small molecule manufacturing at the Hopewell, NJ site.
Responsibilities- develop and implement QC compliance programs
- lead investigations for OOS/OOT/OOE results
- prepare compliance documentation
- manage internal and external GMP audits
- collaborate with QA, Regulatory, Manufacturing, and other departments to ensure regulatory adherence
- and foster a culture of quality and continuous improvement.
- Manage and mentor a team of 1-2 QC compliance professionals, guiding training and performance.
- Bachelor's degree with 8+ years in FDA-regulated biotech/pharma environment
- 5+ years of managerial experience
- extensive knowledge of cGMP/EU GMP for large molecules
- strong leadership
- analytical
- and communication skills
- Master’s degree
- experience with Veeva and LIMS
- and previous compliance leadership.
- GMP compliance
- laboratory investigations
- deviation management
- regulatory documentation
- large molecule manufacturing
- cGMP standards
- FDA/EU regulations
- leadership in a biotech setting.
- on-site in Hopewell, NJ; travel approximately 20%.
Position Requirements
10+ Years
work experience
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