Director, Clinical Program Quality & Excellence (CPQE), Oncology

Role: Senior Quality Leader responsible for asset-level clinical program quality management, focusing on risk-based quality strategies to ensure compliance, data integrity, and patient safety. Objectives include shaping a proactive quality model to enhance clinical performance, regulatory confidence, and expedite time to market; serving as a strategic member of governance bodies to assess risks and drive mitigation; leading inspection readiness efforts across study teams; and fostering a culture of accountability, scientific rigor, and quality by design. Responsibilities encompass developing and executing proactive quality strategies, escalating and investigating Serious GCP breaches, leading global inspection planning, and mentoring teams to embed real-time compliance and inspection readiness. Qualifications: BSc in science or health-related field required; MSc or PhD preferred. At least 10 years’ experience in global pharma, with 5+ years in Quality or Compliance supporting clinical development. Deep knowledge of GCP regulations, clinical lifecycle management, and quality systems; experience in inspections, audits, investigations, and risk management. Skills include strategic leadership, stakeholder influence, communication, and decision-making in complex, cross-functional environments. High-value specifics: Focus on clinical development programs in GCP-compliant environments, with emphasis on inspection readiness, risk-based quality oversight, and a globally integrated approach. Location: USA, Cambridge, MA; full-time, exempt, with no specified travel requirements.