Global Regulatory Director: Audits & Compliance

Takeda; Zürich; Vor Ort; CHF 177.000 - 244.000; Vollzeit

Zusammenfassung

Takeda in Zürich is seeking a Director, Global Regulatory Affairs, Audits, Inspections and Compliance (GRAIC) to provide strategic leadership across global operations and drive a culture of compliant execution.

You will lead audit and inspection readiness, cross-functional collaboration across regions, and continuous improvement of processes and systems, ensuring alignment with Health Authority expectations and lifecycle management.

Qualifikationen

• 12+ years of pharmaceutical industry experience, including at least 3 years within Regulatory Affairs, R&D and/or Quality/Compliance.
• Minimum 3+ years of people leadership experience.
• Strong knowledge of global Health Authorities, PV, license maintenance, product approval and lifecycle processes across major markets.

Aufgaben

• Lead GRA audit and inspection readiness, execution, follow-up activities and continuous improvement.
• Act as the key GRA contact for Global and R&D Quality on audits, inspections and regulatory compliance matters.
• Lead and develop regionally aligned team members, ensuring consistent execution and collaboration across regions.
• Provide regulatory compliance guidance and leadership to cross-functional and regional partners.
• Lead cross-functional workstreams to implement compliance requirements, processes and systems.
• Assess new and revised global regulatory GxP and compliance requirements and evaluate their operational impact.
• Develop and monitor GRA metrics related to regulatory commitments, audits, inspections and Health Authority requests.
• Identify and communicate compliance risks, issues and trends to GRA leadership.
• Oversee issue resolution and CAPAs, driving continuous improvement, automation and process excellence opportunities.

Kenntnisse

Regulatory leadership

Audit & inspection readiness

Cross-functional collaboration

Risk assessment

Project management

Ausbildung

Bachelor's degree in science or business

MSc or PhD preferred

Tools

Veeva RIM

Veeva Quality

TrackWise

Microsoft Office

Jobbeschreibung

Takeda in Zürich is seeking a Director, Global Regulatory Affairs, Audits, Inspections and Compliance (GRAIC) to provide strategic leadership across global operations and drive a culture of compliant execution.

You will lead audit and inspection readiness, cross-functional collaboration across regions, and continuous improvement of processes and systems, ensuring alignment with Health Authority expectations and lifecycle management.