Senior Director / Director – GCP Quality

Role: Senior Director / Director of GCP Quality overseeing clinical GCP and GCLP activities supporting pre-clinical and clinical programs. Responsibilities: act 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. Requirements: BS 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. HighValue: GCP quality oversight, clinical and vendor audits, regulatory inspection preparedness, support for active pre-clinical and clinical programs. WorkSetup: 75% on-site in Boston; collaboration with teams in Boston and Basel.