US-NC, Manager, Quality Management Systems-API Job 451890200A0-MZ
|Requisition ID 53363BR|
Title Manager, Quality Management Systems-API
Job Category Quality
Job Description 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.
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.
•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.
•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 3 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. 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.
Department DAPI US - QA
Position Location US - Clayton, NC
State/Provinces US - NC
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Please visit our website at www.novonordisk.com