Senior Director, Quality - United States Operations (Plainsboro, NJ, US)

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
  • Ensures Quality support to U.S. manufacturing facilities, product warehouses, and Supply Chain to enable product release to the U.S. market
• Quality Governance
  • Oversees development and tracking of Quality activities across U.S. Operations
  • Provides Quality reporting to U.S. Executive Teams, including QAP and QMR

 

Physical Requirements

20-30% overnight travel required.

 

Development of People

Supervisory. Ensures all reporting personnel have annual Individual Development Plans (IDPs) with goals aligned to business priorities. Ensures IDPs include learning and career aspiration plans to enable professional growth and succession readiness. Ensures the communication and application of all Novo Nordisk policies, procedures, and the Novo Nordisk Way.

 

Qualifications

• Bachelor’s degree required; relevant experience may be substituted for degree, when appropriate; advanced degree preferred
• A minimum of 15 years progressively increasing relevant experience preferably in QA and/or GCP; pharma industry preferred with a minimum of 8 years of Quality related experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting
• A minimum of 5 years supervisory experience required
• Demonstrated experience with different GxP areas and core expertise with relation to FDA and other health authority inspections
• Strong analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from international representation at a senior management level
• Demonstrated computer skills (MS Office, MS Project, MS PowerPoint)

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

 

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

 

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Novo Nordisk A/S develops, produces, and markets pharmaceutical products. The Company focuses on diabetes care and offers insulin delivery systems and other diabetes products. Novo Nordisk also works in areas such as haemostatis management, growth disorders, and hormone replacement therapy. The Company offers educational and training materials. Novo Nordisk markets worldwide.