Senior Director, GCP Quality

Role: Sr. Director of GCP Operational Quality responsible for strategic oversight of quality risk management and inspection readiness across clinical programs (e.g., Cystic Fibrosis). Responsibilities: develop and implement quality strategies, oversee risk-based quality principles (QbD, RBQM), lead quality management reviews, collaborate with cross-functional teams (Clinical Ops, Medical Affairs, Regulatory), and guide continuous improvement of GCP quality systems. Requirements: MS with 10+ years or BS with 15+ years relevant experience in biopharma, deep knowledge of GCP regulations, risk management, and operational excellence methodologies (e.g., Lean, Six Sigma). Preferred: experience in regulated environments with biologics or specialty therapeutics, strategic planning, leadership in global or complex settings, and proficiency in quality risk tools. HighValue: role focuses on lifecycle review, proactive risk mitigation, inspection readiness, and aligning quality practices with clinical development milestones. Collaboration: partners closely with QA leadership, clinical teams, and external industry benchmarking. WorkSetup: hybrid or onsite; no explicit travel requirements specified.