EXECUTIVE/SENIOR DIRECTOR, GMP QUALITY & QUALITY MANAGEMENT SYSTEM (QMS)

Job description

Role Overview & Key Functions: Purpose: Provide strategic and enterprise-level leadership of GMP Quality and Quality across GxP domains, through oversight of a robust and integrated Quality Management System (QMS). Lead a team of subject matter experts to ensure the design, implementation, and continuous improvement of quality systems that enable compliant clinical development, pharmacovigilance, and manufacturing operations across the product lifecycle. Strategic Quality Leadership: - Serve as a key member of the Quality Leadership Team , providing strategic direction across GMP Quality and QMS. - Act as the executive sponsor for Quality Systems , ensuring alignment with corporate strategy and regulatory expectations. - Present GMP and QMS performance , trends, and risks to executive leadership, including KPIs and health metrics. Cross-Functional & Enterprise Integration: - Partner with Pharmaceutical Science (CMC), Regulatory IT, and Clinical Quality to ensure QMS integration across GxP domains. - Collaborate with IT to implement and optimize digital QMS solutions. - Ensure alignment between vendor quality systems and internal QMS expectations. Strategic GMP Quality Leadership: -...