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Manager, QA-Purification API

About the Department                                                                                                                                             

At Novo Nordisk, we want to make a difference. For nearly 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Working at our Diabetes Active Pharmaceutical Ingredient (DAPI) manufacturing facility, you will help meet the growing demand for our treatments. Novo Nordisk expects to double production of diabetes and obesity products over the next decade; we have recently completed construction of a 825,000 sq. ft diabetes Active Pharmaceutical Ingredient (API) plant in Clayton, NC. Our new API facility houses the fermentation, recovery and purification of GLP1 ingredients for Novo Nordisk’s innovative oral products. Here, you will work with the best manufacturing professionals in the industry. Are you ready for a life-changing career?
 

Position Purpose

Responsible for facilitating Quality Assurance (QA) related daily operations in Fermentation, Purification or Recovery, as assigned. Manage the operational mode for all aspects of running production within cost, quality & schedule requirements. Supervise & coordinate finance, schedule & planning activities related to operation.

 

Accountabilities

  • Ensure continuous alignment between scope/schedule/cost/risk in operations
  • Stakeholder management within operations & externally to DAPI DK, NNPILP, NP US, external vendors, & NN-Regulatory
  • Coordination with all engineering responsibles, operation responsibles, US management, business support & other relevant stakeholders to ensure strong communication & high level of compliance
  • Coordinating, monitoring & driving all validation activities within area operational area
  • Establish & continuously improve standards within quality oversight, verification, validation, qualification, global process groups
  • Mange the review & release of electronic batch reports for operational area
  • Work with relevant members of all tracks including engineering to ensure aligned priorities on short/medium/long range objectives & goals
  • Meet or exceed customer, business, & regulatory requirements in accordance with Novo Nordisk Way
  • Maintain close working relations with EHS by ensuring all safety & environmental requirements in the performance of duties are maintained
  • Training & development of all employees within operational area
  • Financial responsibility, QA Fermentation/Purification/Recovery, as assigned
  • Lead & support continuous process improvement via cLEAN®
  • Participate as member of QA Management Team in setting plant goals & objectives
  • Support policy development within applicable area (Fermentation/Purification/Recovery) & supporting functions & Clayton QC
  • Other accountabilities, as assigned

 

Required Qualifications

BA/BS in engineering/science related field or equivalent combination of experience & education.  MA/MS in engineering/science is preferred.

 

Desired Qualifications

  • Minimum five (5) years of leadership/management/supervisory (direct or indirect) experience in manufacturing, maintenance, or development processes or programs with a preference toward pharmaceutical or other regulated industries
  • Expert & demonstrated knowledge of US, EU, ROW regulations & guidelines, & application of Good Manufacturing Practices (GMP’s)
  • Expert & demonstrated knowledge of pharmaceutical quality systems (i.e., ICH Q10)
  • Expert & demonstrated knowledge of operational quality oversight
  • Excellent written & oral communication skills
  • Exercises good judgment in decision-making
  • Demonstrated knowledge of LEAN & Six Sigma
  • Knowledgeable in systems within pharmaceutical industries to include parenteral drug production
  • Experience within API production
  • Proven expertise in mentoring/development, change management, planning/organizing, managing execution, & revising the work plan for complex problems solved by cross-functional teams

 

Physical & Other Requirements

  • Occasionally moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions
  • Constantly operates a computer & other office equipment using hands
  • Ability to travel internationally, as needed (up to 10%)
  • Ability to work in an open office environment with the possibility of frequent distraction
  • Ability to work the hours necessary to support a 24/7 continuous manufacturing operation
  • Ability to adjust schedule to work with colleagues in other international time zones

 

RELOCATION IS AVAILABLE FOR THIS ROLE

 

Please submit a cover letter if possible with your application.

 

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status

Millions rely on us 
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. 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.

 

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.

Manager, QA-Purification API

Clayton, NC
Full Time

Published on 07/02/2021

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