Director/Senior Director, Quality
About the Role
The Director/Senior Director, Quality will lead the development, implementation, and continuous improvement of the company's Quality function across Commercial and Clinical Operations. This role will serve as the primary leader for GxP Quality and will be instrumental in building and scaling quality systems, managing external partners, and ensuring compliance with global regulatory requirements. Employment Type Full-time Reports To SVP, Clinical and Medical Affairs
Key Responsibilities
Lead day-to-day Quality operations, overseeing GxP activities to support commercial manufacturing and ongoing clinical trials, including compliance support and issue management Own and manage the Quality Management System (QMS), ensuring compliance with global regulatory standards and alignment with corporate goals Develop and oversee CAPA plans in response to Quality events, audits, and inspections; monitor CAPA effectiveness and closure Manage quality oversight of CMOs, CROs, and other vendors; coordinate external audits and ensure effective supplier qualification and monitoring Implement and maintain quality metrics, systems, and documentation associated with commercial product supply and clinical trials, including procedures, processes, tests, equipment, materials, regulatory requirements, and staffing proficiency Provide leadership and strategic direction across Quality functions including Quality Systems, QA Operations, Supplier Quality, and Clinical Quality Partner with Regulatory Affairs, CMC, Clinical, Supply Chain, and other cross-functional teams to ensure end-to-end GxP compliance Drive continuous improvement initiatives to optimize quality processes, risk management, and inspection readiness Serve as the point person for inspection readiness and regulatory agency inspections related to quality systems
Required Qualifications
Advanced degree (Ph.D., Pharm.D., M.D.) or Bachelor's/Master's degree with relevant experience in life sciences, pharmacy, or related field 10+ years of progressive experience in clinical quality assurance/quality control in the biotech/pharmaceutical industry 3+ years in leadership roles managing QA teams Experience engaging with regulatory agencies (FDA, EMA, etc.) Deep understanding of GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), all other related GxP requirements, ICH guidelines, and global regulatory requirements Experience with clinical trial quality management systems Knowledge of clinical data management and integrity practices Familiarity with risk-based quality management approaches Understanding of CMC (Chemistry, Manufacturing and Controls) as it relates to clinical development
Preferred Qualifications
Experience in commercial-stage biotech or pharmaceutical companies Track record of successfully leading regulatory inspections Experience implementing or upgrading quality management systems Demonstrated ability to build and scale quality functions in growing organizations Salary Apply To This Job