Associate Director, International GVP Compliance

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Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in and promote diversity equity and inclusion. As a company we offer roles based on merit welcoming candidates of any gender age religious belief sexual orientation race color ethnic or social originor disability.

Our team is growing and for this we need bright minds with creativity and flexibility what talent do you have

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.

Empowering our people to shine

At Takeda we earn the trust of society and our customers through our values of Takeda-ism: Integrity Fairness Honesty Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer we offer exciting career paths promote innovation and strive for top performance in everything we do. Takeda fosters an inclusive collaborative and international work environment where our teams are united by their relentless commitment to our goal of improving peoples health and creating a better future for the world.

Diversity Equality and Inclusion

Takeda is committed to foster diversity equality and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender ethnic origin religion sexual orientation age or disability.

If you are interested in this opportunity we look forward to receiving your application via our online tool!

Learn more at

Locations

Zurich Switzerland

Base Salary Range:

CHF159300.00 - CHF219010.00

For information about our benefits please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Required Experience:

Director

Employment Type : Full-Time
Experience: years
Vacancy: 1