Director, Medical Governance Partner

About the role

The Director, Medical Governance Partner serves as the Medical Governance Office's primary global-to-local governance partner, giving practical governance support, advice and expert input to Business Units, regional and country Medical teams. The role provides accountability for the governance framework supporting GxP and other regulated Medical activities globally, while keeping the distinct accountabilities of activity owners, independent Quality, Ethics & Compliance and independent Audit.

Key responsibilities

• Lead the MGO governance framework for GxP and other regulated Medical activities, setting standards, minimum controls, activity classification, decision rights, documentation expectations, escalation routes and interfaces with independent Quality oversight.
• Act as principal governance partner to Business Unit, regional, cluster and country Medical leaders, providing practical guidance and coaching.
• Connect countries with the right MGO capability owners (Evidence Generation, Patient Solutions, Data Dissemination, Grants & Sponsorships and others) and coordinate coherent support.
• Maintain the integrated Global Medical risk register and risk view, identifying material and emerging risks and escalating significant concerns.
• Coordinate proactive GIA audit readiness and Medical audit workstreams, and support readiness for Quality audits and health-authority inspections with R&D Quality, Commercial Quality, Pharmacovigilance, Regulatory Affairs and local owners.
• Support root-cause analysis, CAPA and remediation planning, monitoring significant actions and overdue items at enterprise level.
• Monitor governance performance through risk indicators, KPIs, dashboards and issue tracking, and act as a cross-functional interface with Internal Audit, Quality, Ethics & Compliance, Legal, PV, RA, Privacy, Procurement and others.
• Build a global Medical governance network, capturing country feedback and audit/CAPA themes and turning them into guidance, training inputs, tools and recommendations.

Required profile

• Bachelor's degree in life sciences, pharmacy, medicine, public health, healthcare management, quality, compliance or a related discipline; 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 regulated Medical activities, and with Quality, Ethics & Compliance, Legal, PV, RA and Audit stakeholders.
• Experience guiding global, regional and country Medical teams through governance guidance, risk assessment, audit/inspection readiness, CAPA/remediation and issue management.

Required skills

• Strong knowledge of Medical Affairs governance, quality systems and GxP governance, including risk-based oversight, audit/inspection readiness, root-cause analysis, CAPA and remediation.
• Ability to turn enterprise policies and quality requirements into clear, practical guidance while respecting boundaries between business, MGO, Ethics & Compliance, Quality and Audit.
• Influence without direct authority across geographies and seniority levels, and autonomy within approved MGO direction.