Senior Director/Director – GCP Quality
Listed on 2026-09-14
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Healthcare
Medical Science -
Quality Assurance - QA/QC
Role
Senior Director / Director of GCP Quality overseeing clinical GCP and GCLP activities supporting pre-clinical and clinical programs.
Responsibilitiesact as primary GCP quality contact for vendors and investigator sites, author and review GCP SOPs and procedures, develop risk-based compliance programs, support investigation and CAPA processes, conduct vendor qualification and audits, provide GCP training, ensure audit observation remediation, review regulatory submissions, and lead inspection readiness.
RequirementsBS in Chemistry, Pharmacy, Biology, or related field; 16+ years in pharma/biopharma with clinical development and commercial exposure; in-depth knowledge of GCP, GxP, and global regulations (FDA, EMA, ICH, MHRA); solution-oriented, adaptable, experienced in fast-paced, matrix environments; hands‑on leadership.
High ValueGCP quality oversight, clinical and vendor audits, regulatory inspection preparedness, support for active pre-clinical and clinical programs.
Work Setup75% on-site in Boston; collaboration with teams in Boston and Basel.
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