OpU Lead, Commissioning & Qualification

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Job Description

About the Role

As OpU Lead for Commissioning & Qualification (CQV), you will shape and drive Takeda's CQV strategy across a network of manufacturing sites, ensuring alignment with ASTM E2500, regulatory expectations, and operational excellence. You will lead the development of core CQV competencies, manage vendor performance, and implement best-in-class standards that support Takeda’s ambition to deliver high-quality therapies to patients worldwide.

How You Will Contribute

• Lead and harmonize CQV programs across sites in the region to ensure alignment with global validation frameworks and ASTM E2500 principles.

• Ensure consistency in Site Validation Master Plans and requalification programs in compliance with regulatory and internal standards.

• Build and nurture technical CQV capabilities across site teams, fostering knowledge retention and SME development.

• Provide leadership and technical direction to site engineering and quality teams on CQV execution.

• Manage contractors and external vendors, ensuring quality delivery of CQV services aligned to Takeda’s expectations.

• Drive inspection readiness and ensure CQV-related contributions to regulatory responses are robust and compliant.

• Collaborate cross-functionally across technologies (Plasma, Biologics, Small Molecule, API) to align on SOPs and CQV practices.

• Identify and implement CQV innovations, benchmarking industry best practices and contributing to Takeda's innovation roadmap.

What You Bring to Takeda

• Degree in Engineering (Mechanical, Chemical, Process) or equivalent technical discipline.

• 15+ years of experience in GMP-regulated pharmaceutical manufacturing with strong CQV expertise.

• Minimum 8 years of leadership experience in a matrixed, global organization.

• Deep knowledge of CQV methodologies, including computer system validation, and regulatory frameworks (GxP, FDA, EMA, etc.).

• Proven ability to influence and lead cross-functional and cross-cultural teams at global and site levels.

• Excellent problem-solving, analytical, and strategic thinking skills.

• Effective communicator with the ability to translate complex technical information to stakeholders at all levels.

• Experience managing external vendors and negotiating service contracts.

• Strong business acumen, with understanding of cost, quality, and risk trade-offs.

• Fluent in English (oral and written); additional language skills a plus.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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