Manager, Quality Management Systems API

Facility:  Regulatory
Location: 

Clayton, NC, US

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.

 

Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!

 

Position Purpose

Responsible for leading the DAPI-US Quality Management System (QMS) department & fulfillment of department targets in accordance with the Novo Nordisk Way. Position will oversee all quality management systems at DAPI US.

 

Accountabilities

  • Responsible for leading the QMS department according to PS Leadership competences, including
    • Maintaining compliance with applicable regulations & procedures
    • Target setting & follow-up (performance management)
    • Relevant prioritization of tasks
    • Improvement of productivity through efficient processes
    • Development of employees
    • Ensure high performance & employee engagement
    • Collaboration with customers
    • Contribute to the collective management tasks in the site Quality Management team by participation in strategy development & execution of cLEAN® activities
  • Project Phase: Build QMS and implement current processes from project to operation
  • Ensures effective Regulatory Affairs (RA) local site support & responsibility for site APRs
  • Ensures compliance of Documentation & Records Management
  • Provides coaching & support of Quality Assurance & the site regarding Quality Management System deployment & Regulatory Compliance
  • Ensures effective GMP & Quality Training programs in close collaboration with P&O
  • Additional duties as assigned

 

Required Qualifications

  • BA/BS in Life Sciences, Engineering or related field.  Masters in Life Sciences, Engineering or related field desired
  • Minimum of 7-10 years of experience in the pharmaceutical industry, preferably Aseptic Processing
  • Minimum of 2 years of supervisory experience
  • Minimum of 2 years of project management experience
  • Demonstrated expertise & knowledge of US, EU regulations & guidelines, & application of GMP’s & ISO standards
  • Demonstrated knowledge of Pharmaceutical Quality Systems (i.e. ICH Q10)

 

Desired Qualifications

  • Excellent written & oral communication skills
  • Strong computer skills in MS Office, MS Project, etc.
  • Exercises good judgment in decision-making
  • CQA, CMQ/OE, and/or CQE certification
  • Demonstrated knowledge of LEAN tools
  • Knowledge of training & adult education

 

Physical & Other Requirements

  • Ability to work in & around an active construction site during project phase
  • Ability to work at a computer for extended periods of time
  • Ability to work hours necessary & according to customer needs in a continuous 24/7 operation
  • Able to travel International, as necessary

 

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

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

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.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

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.