Takeda · 1 day ago
Associate Director, GCP Audit and Compliance
Boston, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$154K/yr - $241K/yr
15+ years expTakeda is a patient-focused company transforming patient care through specialty pharmaceuticals. The Associate Director, GCP Audit & Compliance will provide strategic oversight to clinical suppliers, lead audit programs, and ensure compliance with GCP standards.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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
Qualification
Required
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
Preferred
Fluency in additional languages a plus
Benefits
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.
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
Pharma Letter
2026-01-03
2025-12-30
Company data provided by crunchbase