Director – Quality
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Job Description
Director/Senior Director of Quality leading GxP activities for an oncology-focused company. Ensuring compliance and managing quality systems across commercial and clinical operations.
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
Requirements:
- 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
Benefits:
- Health insurance
- Flexible work arrangements
- Professional development opportunities
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