Hybrid Director, Medical Governance, Risk Management

at Novartis

• Job title: Director, Medical Governance, Risk Management
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Dublin, Ireland

About the role

• Director establishing a unified governance framework for medical and patient-focused programs at Novartis. Leading risk management and compliance efforts, fostering a culture of quality and continuous improvement.

Responsibilities

• Implement a unified governance framework for medical and patient-focused programmes, ensuring consistency and compliance.
• Lead the centralised Medical Excellence Governance Board (MEGB) to streamline consultation and escalation pathways for Medical Affairs.
• Build and maintain a governance network across GlobalRegional, and Country Medical Affairs, enabling knowledge sharing and joint problem-solving.
• Onboard, support, train, coach, and mentor country Medical Governance Leads (MGLs), ensuring a strong and knowledgeable team.
• Develop and execute comprehensive self-assessment strategies and controls, analysing trends and providing insights for continuous improvement.
• Guide and mentor associates in managing risks and issues, leading investigations and overseeing CAPA for end-to-end resolution.
• Proactively identify compliance gaps and lead cross-functional projects to address and mitigate risks, ensuring proper documentation and remediation.
• Coordinate audits and manage corrective and preventive actions (CAPA) according to the annual quality audit plan.
• Lead and monitor implementation of quality objectives in alignment with global strategy and quality plans.
• Represent the organization at cross-divisional committees, forums, and boards, ensuring alignment and compliance in global projects.

Requirements

• Master’s degree in a relevant field (e.g., Medical Sciences, Life Sciences, Medicine or related fields).
• Extensive relevant work experience (15+ years) across multiple medical programme or study areas, or diverse expertise in clinical, public health, or pharmaceutical industry (including medical affairs, clinical development, compliance, quality assurance, risk management, regulatory).
• Experience in more than one of these areas is required.
• Deep understanding of health authority requirements, ICH guidelines, GxP processes, and medical guidelines.
• Proven experience in leading self-assessments, audits, and CAPA management.
• Experience working with global teams, cross-functional and cross-divisional collaboration, including country and/or regional roles.
• Proven ability to drive change, build capabilities, and sustain a culture of high ethical standards and compliance.
• Excellent leadership, interpersonal, problem-solving, negotiation, and conflict resolution skills.
• Excellent English language skills, both written and spoken.

Benefits

• Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.