Global Medical Governance Partner: Risk & Audit

Takeda Pharmaceutical Co.; Zürich; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Takeda Pharmaceutical Co. in Zurich, Switzerland, seeks a senior Medical Governance professional to lead the global-to-local governance framework for GxP and other regulated Medical activities.

You will partner with Medical leaders, coordinate with capability owners and manage the enterprise risk view, audits and CAPA remediation. Responsibilities include guiding cross-functional teams, maintaining risk registers, ensuring audit readiness, and shaping governance improvements across Country

Qualifikationen

• Bachelor's degree in life sciences, pharmacy, medicine, public health, healthcare management, quality, compliance or related discipline.
• 10+ years of relevant experience in Medical Affairs, Medical governance, quality/compliance, Medical operations or related functions.
• Experience with GxP and other regulated Medical activities and with Quality, Ethics & Compliance, Legal, Pharmacovigilance, Regulatory Affairs and Audit stakeholders.
• Experience supporting global/regional/country Medical teams through governance guidance, risk assessment, audit or inspection readiness, CAPA/remediation, issue management or continuous improvement.
• Proven success in complex global matrix organizations, including senior stakeholder influence.

Aufgaben

• Lead the MGO governance framework for GxP and other regulated Medical activities globally, ensuring clear standards, minimum controls, activity classification, decision rights, documentation expectations, escalation routes and interfaces with independent Quality oversight.
• Serve as the principal MGO governance partner to Business Unit, regional, cluster and country Medical leaders and activity owners; provide practical guidance and coaching and help teams navigate complex requirements, ownership questions and cross-functional dependencies.
• Connect countries with the appropriate MGO capability owners - including Evidence Generation, Patient Solutions, Data Dissemination, Grants & Sponsorships and other Medical governance domains - and coordinate coherent support without duplicating domain ownership.
• Establish and maintain the integrated Global Medical risk register and risk view; proactively identify material and emerging risks, recurring themes and cross-country issues, support mitigation with accountable owners and elevate significant or unresolved concerns through appropriate governance channels.
• Lead MGO coordination of proactive GIA audit readiness and Medical audit workstreams, including risk-based country preparation, documentation and evidence readiness, SME coordination, issue escalation and enterprise follow-up of findings, while preserving auditor independence.
• Coordinate Medical readiness support for Quality audits and health-authority inspections with R&D Quality, Commercial Quality, Pharmacovigilance, Regulatory Affairs and local activity owners; ensure governance expectations, records and controls are clear and retrievable.
• Support root-cause analysis, CAPA and remediation planning for Medical governance findings; monitor significant actions, overdue items and effectiveness at enterprise level while formal ownership and closure remain with the accountable business or Quality owner.
• Monitor governance performance and adherence through appropriate risk indicators, KPIs, dashboards and issue tracking; provide timely feedback to strengthen processes, systems, tools and country support.
• Act as a key cross-functional interface with Global Internal Audit, R&D Quality, Commercial Quality, Ethics & Compliance, Legal, Pharmacovigilance, Regulatory Affairs, Privacy, Procurement, Digital/DD&T and other relevant functions, facilitating resolution of ownership gaps and handoffs.
• Build a global Medical governance network and continuous-learning loop between countries: capture country feedback, audit/CAPA themes and recurring questions; share effective practices; and translate insights into clearer guidance, 'how-to' materials, training inputs, tools and recommendations for MGO framework improvement.

Jobbeschreibung

Takeda Pharmaceutical Co. in Zurich, Switzerland, seeks a senior Medical Governance professional to lead the global-to-local governance framework for GxP and other regulated Medical activities.

You will partner with Medical leaders, coordinate with capability owners and manage the enterprise risk view, audits and CAPA remediation. Responsibilities include guiding cross-functional teams, maintaining risk registers, ensuring audit readiness, and shaping governance improvements across Country