Associate Director, GCPGVP Supplier Quality

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Job Description

ABOUT THE ROLE

The Associate Director GCP/GVP Supplier Quality provides strategic quality oversight to clinical medical and pharmacovigilance suppliers across Takedas global network. You will lead the risk-based supplier audit program drive compliance insights and partner closely with stakeholders to ensure adherence to GCP GCLP and GVP standards. This role combines audit leadership supplier oversight and strategic risk management to enhance end-to-end clinical quality.

HOW YOU CONTRIBUTE

• Lead strategic quality oversight activities for clinical laboratory medical and PV suppliers.
• Develop execute and continuously improve the global risk-based supplier audit program.
• Conduct supplier audits end-to-end including planning execution reporting and CAPA follow-up.
• Assess and re-evaluate supplier risk categories audit frequencies and key risk indicators.
• Monitor and report compliance metrics to identify trends and escalate emerging risks.
• Support regulatory inspections and internal audits ensuring high-quality deliverables.
• Facilitate complex quality event investigations and contribute to CAPA strategy and effectiveness checks.
• Partner with internal stakeholders to review vendor lists supplier agreements and quality commitments.
• Collaborate with consultant auditor firms and manage operational activities related to audit resourcing.
• Coach and guide junior staff to build auditing capability and strengthen quality culture.

WHAT YOU BRING TO TAKEDA

• Bachelors degree in a scientific health or medical field (or equivalent).
• Minimum 15 years of experience in GCP/GCLP/GVP Quality or Compliance within the pharmaceutical industry.
• Advanced understanding of global GxP regulations (FDA EMA MHRA PMDA ICH).
• Proven experience designing implementing or managing a clinical medical or PV audit program.
• Strong ability to analyze quality risks identify trends and drive continuous improvement initiatives.
• Demonstrated experience managing complex compliance issues and supplier oversight activities.
• Excellent communication skills with the ability to translate complex concepts into actionable insights.
• Experience supporting regulatory inspections and managing cross-functional quality deliverables.
• Ability to influence partner and collaborate across global teams.
• Fluency in written and spoken English; additional languages 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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

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 status as a Vietnam era veteran special disabled veteran or other protected veteran in accordance with applicable federal state and local laws and any other characteristic protected by law.

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Job Exempt