Head, Biopharma QA Operational Strategy and Governance

Head, Biopharma QA Operational Strategy and Governance

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

This position provides strategic and operational leadership for Biopharma Quality Assurance governance across global Astellas Biopharma manufacturing sites and CMOs, ensuring cGMP compliance, inspection readiness, and alignment with Astellas quality standards for clinical and commercial biologics and cell/gene therapy programs. The role exists to drive scalable quality systems, regulatory readiness, product compliance, team development, and cross-functional coordination that enable Biopharma QA to meet business objectives, resolve significant quality risks, and support new technologies, partnerships, and commercialization activities.

Role and Responsibilities

• Lead Biopharma QA Operational Governance and Strategy: As Biopharma QA Leadership Team member, provide strategic and operational leadership to Biopharma QA, ensuring compliance with cGMP regulations and alignment with Astellas’ quality standards. Responsible for supporting Head, Biopharma QA for budget, headcount, OKR planning and administration in alignment with the CSP.
• Oversee GMP Compliance Across Biopharma QA Manufacturing Sites and CMOs: Ensure QA oversight for CTM and Commercialization activities for biologics and cell/gene therapies.
• Manage and Develop High-Performing QA Team: Lead and develop a team of QA professionals, including managers and individual contributors. Provide coaching, mentorship, and clear performance expectations to ensure team success and continued organizational growth.
• Drive Implementation and Optimization of Quality Systems: Support the deployment and continuous improvement of the Astellas electronic Quality Management System (eQMS). Ensure BioPharma site processes meet global standards and are scalable for commercial operations.
• Support Regulatory Readiness and Inspection Activities: Lead QA preparedness activities for regulatory inspections, including PAI readiness and internal audits.
• Lead Product Compliance Management and Issue Resolution: Oversee the timely investigation and resolution of significant quality events, including deviations and CAPAs. Utilize risk-based approaches to drive effective decision-making and maintain compliance.
• Strategic Coordination and Leadership: Provides for leadership, coordination, support and guidance within BioPharma QA, across QA functions and in collaboration with PDM and other functional unit partners. Acts as QA lead for due diligence evaluations and integration for BioPharma technologies.