Associate Director, International GVP Compliance

Associate Director, International GVP Compliance (Cambridge, MA)
Responsibilities / Accountabilities

• Lead regional implementation of global GVP compliance strategies across LOCs; ensure consistent interpretation of regulations and Takeda standards.
• Serve as regional GVP subject-matter expert; guide LOC and regional stakeholders on regulatory expectations, quality system requirements, and inspection readiness.
• Execute/support GVP Quality System processes: deviations, investigations, CAPA management, change control, and escalation.
• Lead high-quality investigations and root-cause analysis; ensure patient-safety focus and prevention of recurrence.
• Track/monitor CAPA development, implementation, and effectiveness; elevate risks, delays, or systemic issues.
• Manage inspection readiness and lead regional/LOC audits and regulatory inspections (preparation, conduct, response, follow-up).
• Partner with Director, Regional GVP Compliance, EU QPPV and PSPV for aligned inspection messaging, issue tracking, and corrective actions.
• Proactively identify/assess compliance risks using audit outcomes, inspection findings, KQIs, and compliance data; support governance and management review materials.
• Support continuous improvement; develop/refine training and compliance guidance; harmonize practices across LOCs.

• Required:
  
  Scientific/allied health qualification (BSc).
• Preferred:
  Advanced degree.
• Required:
  
  7+ years in pharma/healthcare; 4+ years in Pharmacovigilance Quality/Compliance/PV operational roles.
• Strong knowledge of GVP regulations (EU GVP Modules, ICH E2, US CFR) and regional authority expectations.
• Experience with GVP audits/inspections, investigations, and remediation.
• Strong analytical/problem-solving (risk-based thinking), communication, organization, and ethical standards.

• U.S. base salary range (Boston, MA): $–$.
• Benefits info available via link upon application.