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.