Senior Director, Quality - United States Operations

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

Responsible for the leadership of Good Clinical (GCP), Distribution (GDP), and Manufacturing (GMP) Practices (GxP) support across U.S. Quality. Serves as the Quality Responsible Person for U.S. Operations in accordance with SOP194945. Oversees all aspects of advanced document management related to quality assurance, including Quality Docs, SOPs, ISO standards, contracts, promotional material, and regulatory documentation. Provides strategic vision, leadership, and direction for the U.S. Quality Unit and contributes to the strategic direction of CMR Strategic Operations and Operations and Staff Quality. Represents the U.S. in relevant global committees and meetings (e.g., R&D Quality, Global GCP Compliance Focus Group, Global Operation Quality Leadership Team Meetings, Quality Leadership Summit). Leads and implements an effective and compliant Quality Management System (QMS) across U.S. Quality, ensuring alignment with global expectations and partnerships. Serves as the key contact for all U.S. FDA GxP inspections, including GCP, PV, and Devices. Works closely with Regulatory Affairs leadership during inspections. Additionally responsible for oversight of U.S. Patient Safety outsourcing and compliance, including internal pharmacovigilance process adherence, vendor oversight, and CRO oversight. Leads the U.S. self-inspection program, ensuring a robust system of internal quality evaluation and continuous improvement.

 

Relationships

Reports to the Associate Vice President of US Patient Safety, Quality & GxP Compliance (PSQ&GxP). Leads the U.S. Quality organization on all aspects of GxP compliance and maintains strong cross-functional relationships across U.S. Operations and with senior global stakeholders. Ensures adherence to U.S. regulations and company SOPs while driving implementation of the QMS across U.S. Quality. Responsible for communication and conduct during FDA inspections and serves as the Novo Nordisk point of contact for global sponsor inspections by any health authority.

 

Essential Functions

• Strategic Oversight
  • Provides direction on Product Quality, GCP compliance, and vendor management/vendor audits
  • Represents U.S. Quality in Global Operations Quality Leadership Team Meetings
  • Accountable for strategy, timelines, resource deployment, and risk management for the function
  • Ensures U.S. regulatory insights inform Enterprise Quality and R&D Quality strategic initiatives
  • Manages the functional budget, including expenses and contracts
• Leadership
  • Ensures compliance with the Novo Nordisk QMS and drives a strong Quality Mindset across U.S. Quality and CMR
  • Motivates teams to deliver high-quality results
  • Balances competing stakeholders needs and facilitates issue escalation as needed
  • Leads senior management initiatives related to GCP and QA compliance and continuous improvement

• Management
  • Accountable for achievement of productivity metrics for the function
  • Standard Policy Compliance
  • Directs the development and maintenance of SOPs documenting compliance with corporate and regulatory requirements
• Audits & Self-Inspection
  • Leads the development and execution of the U.S. GxP audit plan
  • Oversees internal audits and external inspections (e.g., FDA) across all GxP areas
  • Leads the U.S. self-inspection program, including planning, execution, reporting, CAPA oversight, and trend evaluation

• Product Quality
  • Oversees execution of Quality Management Review (QMR) and follow-up actions
  • Ensu