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Associate Director, Clinical Quality Assurance
Job in
Cambridge, Middlesex County, Massachusetts, 02140, 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
Medical Science
Job Description & How to Apply Below
Associate Director, Clinical QA, providing hands-on quality oversight of biopharma's clinical and nonclinical programs to ensure compliance with GCP, GLP, and GCLP standards.
Responsibilities:- lead audits of CROs, laboratories, and investigator sites domestically and internationally
- manage clinical quality events, deviations, and CAPAs
- review key study documentation
- support vendor qualification, oversight, and inspection readiness
- develop and maintain quality systems and SOPs
- track audit findings and quality metrics
- assist in regulatory submissions and agency inspections
- bachelor's in Life Sciences or related field
- 10+ years in biopharma/clinical research, with at least 7 years in GCP/QA roles
- proven experience leading vendor and site audits, including GLP nonclinical facilities
- working knowledge of ICH E6 (including E6 R3), 21 CFR Parts 11, 50, 54, 56, 58, 312, and EU Clinical Trials Regulation
- ability to travel up to 20%
- clinical and nonclinical audits
- GCP/GLP/GCLP compliance
- vendor oversight
- inspection readiness
- regulatory support
primarily on-site with domestic and international travel.
Position Requirements
10+ Years
work experience
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