Associate Director, GCP Audit and Compliance

Associate Director, GCP Audit and Compliance

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The Associate Director, GCP Audit & Compliance provides strategic quality oversight to clinical, medical, and pharmacovigilance suppliers across Takeda’s 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.

• 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 elevate 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.

• Bachelor’s 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.

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 inspires and empowers employees through life‑changing work. We are a certified Global Top Employer, emphasizing inclusive collaboration and a commitment to better health worldwide.

Takeda is proud of its dedication 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 is proud of 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.

Boston, MA