About the Role
The Medical Governance Office (MGO) serves as the primary global-to-local governance partner, offering practical governance support, expert advice, and input to Business Units, regional, and country Medical teams.
The MGO is accountable for the governance framework that supports GxP and other regulated Medical activities globally, while ensuring that distinct accountabilities of activity owners, independent Quality functions, Ethics & Compliance, and Audit are preserved.
This role assists Medical teams in consistently applying MGO frameworks, standards, minimum controls, and tools; maintains an integrated Global Medical risk view; and supports proactive risk management, audit/inspection readiness, CAPA/remediation follow-up, and escalation.
Acting as a single point of connection between countries, MGO capability owners, and key partner functions, this role utilizes country experience, risk signals, and assurance outcomes to enhance processes, tools, and capabilities, while accelerating 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 to help teams navigate complex requirements, ownership questions, and cross-functional dependencies.
- Connect countries with appropriate MGO capability owners, including Evidence Generation, Patient Solutions, Data Dissemination, Grants & Sponsorships, and other Medical governance domains, coordinating coherent support without duplicating domain ownership.
- Establish and maintain an integrated Global Medical risk register and risk view; proactively identify material and emerging risks, recurring themes, and cross-country issues, and support mitigation with accountable owners while escalating 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 the enterprise level while formal ownership and closure remain with the accountable business or Quality owner.
- Monitor governance performance and adherence using 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 the 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
This role covers a global remit across Business Units, regions, clusters, and countries in a regulated, matrixed environment, accommodating differing local requirements, Medical Affairs maturity, and Quality footprints.
It works across Medical activities with non-GxP, GCP/GVP, and GMP/GDP interfaces. While activity owners retain strategy and execution, MGO sets enterprise Medical governance expectations and risk visibility; Quality retains independent Quality authority; and Audit retains independent assurance responsibilities.
This role 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
This role involves acting as a trusted advisor, coach, and constructive challenger to Medical leaders and teams, promoting early engagement, transparency, learning, and sustainable improvement rather than reactive compliance.
It requires influencing without direct authority across geographies and seniority levels and bringing the right stakeholders together to resolve ambiguity, recurring issues, and cross-functional dependencies.
Decision-Making and Autonomy
Within the approved MGO direction, this role 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.
It decides 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; recommending escalation or enterprise action based on risk and recurrence.
Interaction
This position involves working directly with the Head of the Medical Governance Office and MGO capability leads, while maintaining regular engagement with Business Unit/regional Medical leaders, Cluster Medical Heads, Country Medical Directors, and Medical activity owners.
Coordination is essential with GIA/Enterprise Auditing, R&D Quality, Commercial Quality, Ethics & Compliance, Legal, PV, RA, Privacy, Procurement, Digital/DD&T, and other partner functions.
Innovation
This role identifies opportunities to simplify governance and utilize data, analytics, automation, and approved AI-enabled capabilities to improve risk sensing, governance visibility, audit readiness, knowledge reuse, and decision support.
Complexity
The position 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 a 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 stakeholders in Quality, Ethics & Compliance, Legal, Pharmacovigilance, Regulatory Affairs, and Audit.
- Experience supporting global, regional, or 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 while managing cross-functional actions, escalation, and follow-through.
- Behavioral Competencies: Trusted-partner and customer-focused mindset with strong listening, coaching, facilitation, and stakeholder-management skills.
- Excellent executive communication and judgment; capable of framing complex governance issues, risks, implications, and recommendations clearly while challenging 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 are advantageous.
Apply online using the form below. Only applications matching the job profile will be considered.