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Logistics Quality & Regulatory Professional

About the Department

At Novo Nordisk, we want to make a difference. For more than 95 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. Help us bring quality to life. 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 drugs over the next decade and are currently building a new 825,000 sq. ft diabetes Active Pharmaceutical Ingredient (API) plant in Clayton, NC next to our existing “fill and finish” manufacturing facility. Our new $2 billion API facility is expected to be operational in 2020, with 700 full-time employees responsible for the fermentation, recovery and purification of insulin and GLP1 ingredients. This once in a life-time career opportunity is ideal for pharmaceutical manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us build, validate, and run our processes. Here, you will work with the best manufacturing professionals in the industry. Are you ready to make a difference?

 

 

Position Purpose:  

Provide routine support & troubleshooting for DAPI US Supply Chain planning, logistics, operations & facilities.  Act as department quality coordinator for all supply chain projects & operations.  Drive supply chain audit preparation program & prepare presentations in support of audits & inspections.  Responsibilities include:

  • Change Request (CR) responsibilities: collaborate with QA/QC on strategy, structure & process development.
  • Author & support deviations & CAPAs.
  • Author & revise SOPs, JI & other procedures.
  • Oversee Quality Management Review (QMR) Warehouse, Raw Materials, & Sampling QC.
  • Responsible for coordinating & collaborating with QA, QC & Regulatory Departments on all Warehouse, Raw Materials & Sampling QC processes
  • Process expert for incoming raw materials & sampling.

 

Accountabilities:

  • Build up needed compliance systems & collaboration with QA/QC on strategy, structure & process development for warehouse.
  • Responsible for all SOP, CR & QMR schedule adherence for warehouse, sampling & QC Raw Materials.
  • Act as department quality coordinator during project & operation.
  • Manage program for warehouse & QC quality systems audit & inspection readiness.
  • Gather & ensure knowledge transfer & alignment on all Raw Material warehouse, sampling & QC Raw Materials practices & procedures between Denmark & DAPI-US, ensuring coordination & collaboration with all relevant stakeholders.
  • Drive implementation of cLEAN® (LEAN/Six Sigma) principles in QC warehouse operations.
  • Other accountabilities, as assigned.

 

Required Qualifications

  • BA/BS in pharmaceutical, quality, engineering or related field.  (MA/MS preferred.)
  • Minimum of eight (8) years of relevant experience
  • Minimum of five (5) years of experience operating in a GMP-regulated environment
  • Experience with building up quality systems
  • Knowledge about requirements & expectations from authorities, e.g. Food & Drug Administration (FDA)

 

Desired Qualifications

  • Proven ability to establish & maintain networks & to facilitate processes that encourage cross organizational knowledge sharing.

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 30 pounds within the facility
  • Constantly operates a computer & other office equipment using hands
  • Ability to move throughout the facility in the performance of duties in proximity to process equipment & areas
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation
  • Able to adjust schedule to work with colleagues in other international time zones
  • Able to travel domestically or internationally, if necessary

 

 

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.

 

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

 

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.

Logistics Quality & Regulatory Professional

Clayton, NC
Full Time

Published on 02/18/2020