Director, Patient Safety Operational Excellence Lead

About the Department

 

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

 

 

The Position

The Patient Safety, Compliance & Operational Excellence Lead is responsible for driving efficiency, quality, and innovation across US Quality, GxP Compliance Training and Patient Safety Operations. This role ensures that Safety/Quality/Training processes, systems, and resources are optimized to support regulatory compliance while enabling scalability, automation, and continuous improvement.

 

Relationships

Reports to the Executive Director, PS & GxP Business Operations. Accountable for establishing and managing relationships with local and global key stakeholders. May have direct reports or indirect reports.

 

Essential Functions

• Operational Excellence & Process Improvement
  • Lead initiatives to streamline Safety/Quality/Training processes
  • Apply Lean Six Sigma or other methodologies to eliminate inefficiencies and improve throughput
  • Drive harmonization of workflows across affiliates, partners, and vendors
• Performance Monitoring & Insights
  • Define and monitor Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) for Safety/Quality/Training operations
  • Develop and maintain performance dashboards for leadership visibility
  • Provide insights and recommendations for proactive risk mitigation and capacity planning and allocations across internal and external resources
• Technology & Innovation
  • Partner with appropriate departments to assist with the implementation and optimization of safety/quality/training systems
  • Drive adoption of digital tools (AI-assisted case processing, NLP, automation, analytics platforms)
  • Support system change control, validation, and upgrade activities
• Governance & Change Management
  • Support Safety/Quality/Training leadership in operational and governance meetings
  • Lead cross-functional improvement projects with stakeholders from Quality, Regulatory Affairs, IT, and Global Units
  • Manage change initiatives to ensure successful adoption across global teams
• Continuous Improvement & Compliance
  • Collaborate with Quality to address recurring CAPAs through process redesign and sustainable solutions
  • Conduct root cause analyses for deviations or performance issues
  • Promote a culture of continuous improvement and operational excellence

 

Physical Requirements

0-10% overnight travel required.

 

Development of People

Supervisory. Train, mentor, and guide direct or indirect team members to enhance their skills and competencies.

 

Qualifications

• Bachelor’s degree required with a focus in Finance, Business Administration, or similar
• Advanced degree preferred (MBA or other relevant advanced degree)
• A minimum of 10 years’ experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting, with at least 5 of those working in or supporting a clinical, medical and/or regulatory organization, in the pharmaceutical industry (Pharma/Biotech/CRO)
• Experience in leading teams (local required, global preferred)
• Strong decision-making skills through demonstrated ability to leverage existing or forecasted data into strategy development, resource models, and optimization of plans for the organization
• Ability to work independently or within teams in a global and agile environment; strong or