Director, Medical Governance Partner

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

Job Description

About the role

• Serves as the Medical Governance Office's primary global-to-local governance partner, providing practical governance support, advice and expert input to Business Units, regional and country Medical teams.
• Provides MGO accountability for the governance framework supporting GxP and other regulated Medical activities globally, while preserving the distinct accountabilities of activity owners, independent Quality functions, Ethics & Compliance and independent Audit.
• Helps Medical teams apply MGO frameworks, standards, minimum controls and tools consistently; maintains the integrated Global Medical risk view and supports proactive risk management, audit/inspection readiness, CAPA/remediation follow-up and escalation.
• Acts as a single point of connection between countries, MGO capability owners and key partner functions, using country experience, risk signals and assurance outcomes to improve processes, tools and capabilities and accelerate country support and decision-making.

How you will contribute

• 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.

Dimensions and Aspects

• Global remit across Business Units, regions, clusters and countries in a regulated, matrixed environment with differing local requirements, Medical Affairs maturity and Quality footprints.
• Works across Medical activities with non-GxP, GCP/GVP and GMP/GDP interfaces. Activity owners retain strategy and execution; MGO sets enterprise Medical governance expectations and risk visibility; Quality retains independent Quality authority; Audit retains independent assurance responsibilities.
• Creates value for countries by providing an accessible route into MGO, reducing navigation complexity, connecting teams to the right expertise early and helping resolve governance issues before they become recurring findings or execution barriers.

Technical / Functional Expertise

• Strong knowledge of Medical Affairs governance, quality systems and governance of GxP and other regulated Medical activities, including risk-based oversight, audit/inspection readiness, root-cause analysis, CAPA and remediation.
• Ability to translate enterprise policies, standards and quality requirements into clear, practical guidance while maintaining appropriate boundaries between business ownership, MGO governance, Ethics & Compliance, independent Quality and Audit.

Leadership

• Acts as a trusted advisor, coach and constructive challenger to Medical leaders and teams; promotes early engagement, transparency, learning and sustainable improvement rather than reactive compliance.
• Influences without direct authority across geographies and seniority levels and brings the right stakeholders together to resolve ambiguity, recurring issues and cross-functional dependencies.

Decision-Making and Autonomy

• Within approved MGO direction, determines the operating approach for global-to-local governance partnership, enterprise Medical risk visibility, proactive country support, audit-readiness coordination and cross-country issue follow-up.
• Determines when MGO guidance is sufficient and when formal input or decision is required from Quality, Ethics & Compliance, Legal, Privacy, Pharmacovigilance, Regulatory Affairs or another accountable function; recommends escalation or enterprise action based on risk and recurrence.

Interaction

• Works directly with the Head, Medical Governance Office and MGO capability leads and maintains regular engagement with Business Unit/regional Medical leaders, Cluster Medical Heads, Country Medical Directors and Medical activity owners.
• Coordinates closely with GIA/Enterprise Auditing, R&D Quality, Commercial Quality, Ethics & Compliance, Legal, PV, RA, Privacy, Procurement, Digital/DD&T and other partner functions.

Innovation

• Identifies opportunities to simplify governance and use data, analytics, automation and approved AI-enabled capabilities to improve risk sensing, governance visibility, audit readiness, knowledge reuse and decision support.

Complexity

• Balances global consistency with valid local requirements across multiple Medical governance domains and functions, operating through partnership and matrix leadership rather than direct control of country teams.

Skills and qualifications

Education & Experience

• Bachelor's degree in life sciences, pharmacy, medicine, public health, healthcare management, quality, compliance or related discipline required; advanced degree preferred.

• 10+ years of relevant experience in Medical Affairs, Medical governance, quality/compliance, Medical operations or related functions in the biopharmaceutical or healthcare industry.

• Demonstrated 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.

Technical Skills

• Strong knowledge of Medical governance, regulated-activity governance, risk-based oversight, audit/inspection readiness, CAPA and sustainable remediation.
• Strong analytical and systems-thinking skills; able to connect individual country issues to enterprise patterns and maintain meaningful risk views, metrics and dashboards.
• Ability to create concise, practical governance guidance, decision aids, checklists, playbooks and learning materials and to manage cross-functional actions, escalation and follow-through.

Behavioural Competencies

• Trusted-partner and customer-focused mindset with strong listening, coaching, facilitation and stakeholder-management skills.
• Excellent executive communication and judgment; able to frame complex governance issues, risks, implications and recommendations clearly and challenge constructively.
• Collaborative, pragmatic and culturally sensitive working style with strong ownership, follow-through and commitment to transparency, learning and continuous improvement.

Languages

• Fluent English required; additional languages advantageous.

Additional Information

• Dedicated MGO role focused on global-to-local Medical governance partnership, governance of GxP and other regulated Medical activities, enterprise Medical risk visibility, proactive audit readiness, CAPA/remediation support and continuous governance learning.
• Country and Business Unit Medical teams retain accountability for local implementation and activity execution. The role guides, coordinates, monitors, challenges and escalates but does not implement local governance requirements on their behalf.

Locations

Zurich, Switzerland

Base Salary Range

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time