Associate Director, International GVP Compliance

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.

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.