Global Medical Governance Partner for GxP & Audit Readiness

Takeda Pharmaceutical Co.; Schweiz; Hybrid; EUR 190.000 - 253.000; Vollzeit

Zusammenfassung

Takeda Pharmaceutical Co. is seeking a seasoned leader to run the Medical Governance Office’s global-to-local governance partnership.

You will provide practical governance input to Business Units, regional Medical teams and country Medical leaders, ensuring GxP and other regulated activities are governed with clear standards and minimised risk. Based in Zurich, Switzerland, the role involves coordinating across Global Internal Audit, QA, Ethics & Compliance, Regulatory Affairs and other

Qualifikationen

• Bachelor’s degree in life sciences, pharmacy, medicine, public health, healthcare management or related discipline.
• 10+ years of experience in Medical Affairs, Medical governance, quality/compliance or related fields.
• Demonstrated experience with GxP and regulated activities and with stakeholders across QA, Ethics & Compliance, Legal, Pharmacovigilance and Regulatory Affairs.

Aufgaben

• Lead the MGO governance framework for GxP and other regulated Medical activities globally with clear standards and interfaces.
• Serve as the principal governance partner to Medical leaders and owners; provide guidance and coaching across jurisdictions.
• Coordinate across countries with MGO capability owners to ensure consistent support and avoid duplications.
• Maintain the integrated Global Medical risk register and proactively identify risks and cross-country issues.
• Lead MGO coordination for audit readiness and Medical audit workstreams with risk-based country preparation and evidence readiness.
• Coordinate Medical readiness for quality audits and health-authority inspections with cross-functional teams.
• Support root-cause analysis, CAPA and remediation for governance findings with timely closure.
• Monitor governance performance via KPIs, dashboards and issue tracking and escalate as needed.
• Act as cross-functional interface with Internal Audit, Quality, Ethics & Compliance, Legal, Pharmacovigilance, Regulatory Affairs and other functions.
• Build a global Medical governance network and share best practices and learning materials.

Kenntnisse

Medical governance

Quality systems

Risk management

Stakeholder management

Audit readiness

GxP

Ausbildung

Bachelor's degree in life sciences

Advanced degree preferred

Jobbeschreibung

Takeda Pharmaceutical Co. is seeking a seasoned leader to run the Medical Governance Office’s global-to-local governance partnership.

You will provide practical governance input to Business Units, regional Medical teams and country Medical leaders, ensuring GxP and other regulated activities are governed with clear standards and minimised risk. Based in Zurich, Switzerland, the role involves coordinating across Global Internal Audit, QA, Ethics & Compliance, Regulatory Affairs and other