Director, Clinical Quality – Program and Process Quality

Job Description: • Define and drive a strong GCP quality culture across clinical programs. • Oversee clinical quality systems and metrics, anticipate and escalate risk before it becomes an issue. • Work with Clinical Operations, Regulatory, Safety, and other partners to keep trials inspection-ready. • Support and develop Clinical Quality team members guiding inspection readiness, deviations, investigations, audits, and CAPAs. • Shape an integrated, proactive clinical quality strategy that scales with the pipeline. • Develop and report key quality metrics across all clinical programs and trials. • Assess current-state quality across programs, processes, and trials. • Identify trends, risks, and lead process and system improvements. • Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations. • Author standard operating procedures and related documents. • Monitor regulatory changes and assess impact to programs. • Provide guidance and mentorship to clinical quality staff assigned to clinical programs and supporting study teams. Requirements: • Bachelor’s degree in a scientific field required; advanced scientific degree a plus  . • 10+ years industry experience directly managing GCP/GPvP QA activities, audits, inspections, CAPAs, and risk management. • Must have worked within Sponsor organization although can be in combination with academic and/or CRO experience  . • In-depth knowledge of quality, compliance, risk management, clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements  . • Experience mentoring and directing members of quality and clinical operations teams  . • Experience working in a team across multiple functional areas (e.g., CMC / GMP Quality, Data Management, Biostats, Safety, Clinical Supply)  . • Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit  . • Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to create solutions and enable decisions  . • Self-motivated and able to work autonomously, as well as a member of a high-functioning and collaborative team  . Benefits: • 99% of the premium paid for medical, dental and vision plans. • Company-paid life insurance, AD&D, disability benefits, and voluntary plans. • 401(k) matching dollar-for-dollar up to 6% on eligible contributions. • Long-term stock incentives and ESPP. • Discretionary quarterly bonus. • Extremely flexible wellness benefit. • Generous PTO, paid holidays and company-wide shutdowns. Apply tot his job Apply To this Job