Senior NAO Quality, Product Quality Manager

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

This position is responsible for developing Quality and NAO strategic objectives and strong business understanding of the value chain and customer focus, for supporting and upholding processes anchored in the Novo Nordisk Quality Management System across NAO thereby ensuring highest quality to patients. In addition this position is primarily responsible for activities related to safeguarding the quality of all product released for market in the United States. This position is responsible for the tactical execution of quality-based review and disposition for all exceptions related to storage and distribution of product by sales representatives and supporting training relative to proper handling of product by sales representatives. This position is also responsible for supporting other processes in the Novo Nordisk Quality Management System as well as driving continuous improvement projects within the department, affiliate, and/or in collaboration with global colleagues.

Relationships

Reports to the Associate Director Product Quality. Regularly interfaces with multiple NN Quality departments. Additional regular stakeholders include NNI Commercial business unit. Drives and maintains positive rapport and working relationships within and across departments in relationship to business improvement projects. External relationships include e.g. routine networking through membership in industry association(s).

Essential Functions

• Drive value creation and link quality to business by supporting Sample Operations with their Must Win Battles and key business decisions
• Product Quality:
  • Evaluates, and dispositions temperature excursions of sample product
  • Investigates, evaluates, and dispositions storage and transport issues of sample product by sales force
  • Develops and maintains reporting and evaluation process for sales representative refrigerator thermometers including replacement and calibration
  • In collaboration with the Commercial business unit and the Strategy, Finance, & Operations business units, develops and executes relevant sales force training as it relates to assuring high product quality is maintained throughout the U.S. supply chain
  • Participates in various global product quality activities and projects
  • Maintains up-to-date knowledge of the Regulations and Guidelines issued by the FDA along with other industry periodicals impacting pharmaceutical product quality issues

• Deviations:
  • Manage deviations resulting from the U.S. sales force including registration, investigation and implementation of corrective actions
• Quality Assurance:
  • Provides secondary support to all NAO Quality processes, including but not limited to ISOtrain, Document Control, and/or Audits and Inspections, as necessary

Physical Requirements

10-20% overnight travel required.

Qualifications

• Bachelors degree required; relevant experience may be substituted for degree, when appropriate; advanced degree and/or external certification (e.g ASQ, PMI) preferred
• Requires a minimum of 7 years of progressively responsible, relevant experience, with at least 2 years in area of specialty; pharma experience preferred
• Ability to proactively anticipate multiple deadlines, and drive and manage priorities is required
• Excellent speaker and/or presentation skills
• Exceptional interpersonal skills and the ability to interact with staff on all levels and within a culturally diverse environment
• Expert project management and organizational skills

The base compensation range for this position is $120,000 to $160,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.  
 
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.  
 
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. 

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.