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.

Required Qualifications

• BS/BA in Life Sciences, Engineering, or Chemistry with 10+ years of experience in a GMP-regulated biotechnology or pharmaceutical industry. Prior experience in cell therapy or gene therapy manufacturing is a plus.
• Experience in Quality Assurance role in 3+ years
• In-depth knowledge of GMPs relevant to global (US, EU, JP) clinical and commercial manufacturing regulations, with a broad knowledge of quality principles and regulatory trends
• Proven written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the Astellas groups and with external stakeholders.
• Ability to develop and maintain effective relationships with internal and external partners including Global Astellas entities.
• Demonstrated ability to apply industry knowledge to anticipate global impact and contribute to strategic QA planning.
• Experience managing multiple QA functions with limited oversight, and leading execution of quality strategies with input from senior management.

Preferred Qualifications

• In-depth knowledge of global industry standards and regulatory requirements (US, EU, and Japan)
• Experience in aseptic processing
• Demonstrated experience in directing and coaching individuals and project teams (3-5+ years managerial experience)
• Experience in budget management and strategic planning
• Direct experience in Manufacturing Operations and Commercial Readiness
• Applied knowledge/audit experience in Biologics, Parenteral, Medical Device, Combination Products and/or Regenerative medicines or new modalities

Location and Working Environment

• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency.  We are outcome focused and consistently take accountability for our personal contribution.

Salary Range

$170,450-$243,500 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions
• Referral bonus program

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