Director, Clinical Program Quality

Role: Director of Clinical Program Quality responsible for developing and leading a risk-based quality management strategy across clinical assets in gastroenterology and inflammation. Objectives include enhancing compliance, program performance, and regulatory confidence, while accelerating time to market through early risk identification and mitigation. Responsibilities encompass providing strategic oversight on critical quality issues, leading investigations of serious breaches and misconduct, driving inspection readiness, shaping global GCP inspection strategies, and implementing risk-based audit plans. The role involves stakeholder engagement within governance forums, mentoring teams, and promoting a culture of accountability and scientific rigor. Requirements: BSc in a scientific or health-related field; 10+ years in the pharmaceutical industry with at least 5 years in quality or compliance supporting clinical development; extensive knowledge of GCP regulations across the clinical lifecycle; demonstrated experience in quality systems oversight, regulatory inspections, and complex investigations. Preferred qualifications include advanced degrees (MSc or PhD). HighValue: focus on GCP compliance, inspection readiness, risk management, and quality leadership within clinical research. Location: Boston, MA with full-time employment. The role reports to the Head of Clinical Program Quality, Gastrointestinal and Inflammation.