Associate Director, GCP Audit and Compliance

Takeda • Boston, MA

12d

About The Position

ABOUT THE ROLE 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.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees