Director, Medical Governance Partner

Global Medical Governance Partner

Serve as the primary global-to-local governance partner for the Medical Governance Office, providing practical support, advice, and expert input to Business Units, regional, and country Medical teams. This role ensures 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.

Key Responsibilities

• 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.
• Act as the principal governance partner to Business Unit, regional, cluster, and country Medical leaders, providing practical guidance, coaching, and assistance in navigating complex requirements, ownership questions, and cross-functional dependencies.
• Connect countries with appropriate MGO capability owners, including Evidence Generation, Patient Solutions, Data Dissemination, and Grants & Sponsorships, coordinating coherent support without duplicating domain ownership.
• Establish and maintain the integrated Global Medical risk register, proactively identifying material and emerging risks, recurring themes, and cross-country issues to support mitigation and escalation through appropriate governance channels.
• Lead MGO coordination of proactive audit readiness and Medical audit workstreams, including risk-based country preparation, documentation readiness, SME coordination, 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 to ensure governance expectations, records, and controls are clear and retrievable.
• Support root-cause analysis, CAPA, and remediation planning for Medical governance findings, monitoring significant actions, overdue items, and effectiveness at the enterprise level.
• Monitor governance performance and adherence through risk indicators, KPIs, dashboards, and issue tracking to provide timely feedback for strengthening processes, systems, and tools.
• Act as a key cross-functional interface with Global Internal Audit, Quality, Ethics & Compliance, Legal, Pharmacovigilance, Regulatory Affairs, Privacy, Procurement, and Digital/DD&T to facilitate the resolution of ownership gaps and handoffs.
• Build a global Medical governance network and continuous-learning loop by capturing country feedback, sharing effective practices, and translating insights into clearer guidance, training inputs, and framework improvements.

Scope and Impact

Operate within a global remit across Business Units, regions, clusters, and countries in a regulated, matrixed environment. This role works across Medical activities with non-GxP, GCP/GVP, and GMP/GDP interfaces, creating value by providing an accessible route into MGO, reducing navigation complexity, and helping resolve governance issues before they become recurring findings or execution barriers.

Required Expertise and Leadership

• Demonstrate strong knowledge of Medical Affairs governance, quality systems, and the governance of GxP and other regulated Medical activities, including risk-based oversight, audit/inspection readiness, root-cause analysis, CAPA, and remediation.
• 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.
• Act as a trusted advisor, coach, and constructive challenger to Medical leaders, promoting early engagement, transparency, learning, and sustainable improvement rather than reactive compliance.
• Influence without direct authority across geographies and seniority levels, bringing the right stakeholders together to resolve ambiguity, recurring issues, and cross-functional dependencies.
• Determine the operating approach for global-to-local governance partnership, enterprise Medical risk visibility, and proactive country support within approved MGO direction.
• Identify opportunities to simplify governance using data, analytics, automation, and approved AI-enabled capabilities to improve risk sensing, governance visibility, and decision support.

Qualifications and Skills

• Bachelor's degree in life sciences, pharmacy, medicine, public health, healthcare management, quality, compliance, or a related discipline is required; an advanced degree is 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, as well as collaboration with Quality, Ethics & Compliance, Legal, Pharmacovigilance, Regulatory Affairs, and Audit stakeholders.
• Experience supporting global, regional, and 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.
• Strong analytical and systems-thinking skills, with the ability 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.
• Trusted-partner and customer-focused mindset with strong listening, coaching, facilitation, and stakeholder-management skills.
• Excellent executive communication and judgment, with the ability 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.
• Fluent English is required; additional languages are advantageous.