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The Associate Director, International GVP Compliance plays a critical role in ensuring the effective implementation and execution of Good Pharmacovigilance Practice (GVP) compliance across assigned international regions. This position partners closely with Local Operating Companies (LOCs), regional Patient Safety and Pharmacovigilance (PSPV) stakeholders, and Global GVP Compliance teams to translate global compliance strategies into consistent regional practices.
The role is responsible for strengthening GVP Quality System execution, driving inspection readiness, leading compliance investigations and CAPA activities, identifying emerging compliance risks, and supporting continuous improvement initiatives that protect patient safety and maintain regulatory integrity. The Associate Director serves as a trusted compliance advisor and subject matter expert, helping build a risk-based, inspection-ready pharmacovigilance compliance culture across the region.
Key Responsibilities
GVP Compliance Leadership
- Lead within assigned region, implementation of global GVP compliance strategies, ensuring consistent interpretation and application of regulations and Takeda standards across LOCs.
- Act as a regional GVP compliance subject-matter expert, providing guidance to LOC and regional stakeholders on regulatory expectations, quality system requirements, and inspection readiness.
GVP Quality Systems
- Execute and support core GVP Quality System processes regionally, including deviations, investigations, CAPA management, change control, and escalation.
- Lead high-quality investigations and root-cause analysis, ensuring patient-safety focus and effective prevention of recurrence.
- Track, monitor, and support CAPA development, implementation, and effectiveness, escalating risks, delays, or systemic issues to regional leadership as appropriate.
Inspection Readiness, Audits & Inspections
- Manage regional inspection readiness activities, helping embed readiness into routine PV operations rather than point-in-time preparation.
- Lead in regional and LOC-level audits and regulatory inspections, supporting preparation, inspection conduct, response development, and follow-up activities.
- Partner with the Director, Regional GVP Compliance, EU QPPV and PSPV to support aligned inspection messaging, issue tracking, and corrective actions.
Compliance Risk Management & Governance
- Drive proactive identification and assessment of regional compliance risks by analyzing audit outcomes, inspection findings, KQIs, and compliance data.
- Contribute regional insights to risk discussions and governance forums, supporting preparation of materials for Management Review and Clinical & Safety Quality Councils.
- Ensure consistent, timely escalation of critical compliance issues, providing analysis and recommendations to regional leadership.
Continuous Improvement & Capability Building
- Support continuous improvement initiatives driven by regulatory feedback, audit trends, and quality analytics, translating insights into actionable regional improvements.
- Contribute to the development and refinement of regional training, inspection readiness materials, and compliance guidance, ensuring practicality and regulatory relevance.
- Support knowledge sharing and harmonization of practices across LOCs to strengthen regional consistency and compliance maturity.
Qualifications
Education & Experience
- Scientific or allied health qualification required (BSc); advanced degree preferred.
- 7+ years of experience in the pharmaceutical or healthcare industry, with 4+ years of experience in Pharmacovigilance Quality, Compliance, or PV operational roles.
- Strong working knowledge of GVP regulations, including EU GVP Modules, ICH E2 guidelines, US CFR, and key regional authority expectations.
- Experience supporting GVP audits, regulatory inspections, investigations, and remediation activities.
Skills & Competencies
- Strong analytical and problem-solving skills, with the ability to apply risk-based thinking.
- Effective collaborator with the ability to influence without direct authority in matrix environments.
- Clear written and verbal communication skills, with confidence engaging regional and cross-functional stakeholders.
- Highly organized and detail-oriented, able to manage multiple priorities in a dynamic environment.
- High ethical standards, resilience, and commitment to patient safety and regulatory compliance.
- Open-minded, appropriately risk-tolerant, and resilient, demonstrating humility, openness to challenge, and constructive debate.
- Unwavering integrity and ethical standards, with a strong commitment to patient safety, scientific rigor, and regulatory compliance.
