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