Associate Director, International GVP Compliance
Takeda
September 02, 2026
On-site
Boston, MA
$154,400 - $242,550 USD yearly
Operations
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; escalate 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.
Qualifications (Required/Preferred)
- 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.
Compensation/Benefits
- U.S. base salary range (Boston, MA): $154,400.00–$242,550.00.
- Benefits info available via link upon application.
Application instructions
- Click “Apply” to begin the employment application process; application data is processed under Takeda’s Privacy Notice and Terms of Use.
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; escalate 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.
Qualifications (Required/Preferred)
- 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.
Compensation/Benefits
- U.S. base salary range (Boston, MA): $154,400.00–$242,550.00.
- Benefits info available via link upon application.
Application instructions
- Click “Apply” to begin the employment application process; application data is processed under Takeda’s Privacy Notice and Terms of Use.