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

Secura Bio was established in 2019 with a singular mission: to close the gap between innovative oncology therapies and the patients who need them most. Our high-touch approach is informed by our decades of experience shaping the impact of oncology’s largest clinical and market opportunities. We know that true impact comes from personalization and an unwavering commitment to serve patients and expand the possibilities of life-prolonging oncology medicines.

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