Posted to MedZilla HealthCare on 4/21/2018


Novo Nordisk

US-NC, Manager, Quality Managment Systems API Job 467444000A0-MZ


 
 

Your Groundbreaking Journey

At Novo Nordisk, we want to make a difference. For more than 90 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 and improve the quality of life for millions of people around the world.

To help meet the growing demand for our diabetes treatment, Novo Nordisk expects to double production of diabetes drugs over the next decade. Novo Nordisk is currently building a new diabetes API plant in Clayton, NC next to our existing facility that employs 800 people. The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.

Novo Nordisk is currently seeking top talent for this green field project and eventual operations. This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build. Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.

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:

o Maintaining compliance with applicable regulations & procedures;

o Target setting & follow-up (performance management);

o Relevant prioritization of tasks;

o Improvement of productivity through efficient processes;

o Development of employees;

o Ensure high performance & employee engagement;

o Collaboration with customers;

o 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.


Education:

•BA/BS in Life Sciences, Engineering or related field. Masters in Life Sciences, Engineering or related field desired. MANDATORY


Experience: MANDATORY

•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.


Technical/Process/Functional Knowledge:

•Demonstrated expertise & knowledge of US, EU regulations & guidelines, & application of GMP’s & ISO standards. MANDATORY

•Demonstrated knowledge of Pharmaceutical Quality Systems (i.e. ICH Q10). MANDATORY

•Excellent written & oral communication skills. PREFERRED

•Strong computer skills in MS Office, MS Project, etc. PREFERRED

•Exercises good judgment in decision-making. PREFERRED

•CQA, CMQ/OE, and/or CQE certification. DESIRED

•Demonstrated knowledge of LEAN tools. DESIRED

•Knowledge of training & adult education. DESIRED


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.


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.



Requisition ID: 55414BR
State/Provinces: Clayton
Job Category: Quality


Please visit our website at www.novonordisk.com

 
 


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