Posted to MedZilla on 1/19/2019


Novo Nordisk

US-NC, Sr. QMS Area Specialist I Job 530021600A0-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:
Ensure local quality processes are in compliance with cross-functional requirements as well as regulatory requirements. Design & develop quality & compliance set-up for global systems during DAPI-US project. Ensure compliant execution & monitoring. Drive corrective actions & quality improvement initiatives within production.

Accountabilities:

  • Formulate continuous improvement tools for QA compliance operations.

  • Ensure compliance with regulations, ISO standards & corporate & local SOPs.

  • Support Internal & Regulatory Audit program, being a liaison between QMS & production for audit readiness.

  • Support metrics for Quality System process improvements.

  • Provide coaching to QA Compliance & Site regarding quality-related activities.

  • Prepare & approve documents regarding QA department related activities.

  • Support, review & approve complex cross-functional investigations & root-cause analysis.

  • Review & approve change control requests.

  • Assist in plant-wide training on regulations, Quality systems & procedures.

  • Coordinate tasks of QA Compliance Specialists to assure compliance with company procedures, policies & objectives.

  • Participate in knowledge & experience sharing to ensure collaboration, communication & create results in relation to compliance with company procedures, policies & objectives.

  • Ensure quality & compliance.

  • Perform other duties, as assigned.

REQUIRED QUALIFICATIONS:

  • BA/BS required (Life Science, Engineering or related field preferred).

  • Minimum of five (5) years of QA and/or related experience in pharmaceutical or medical device industry with progressively increasing responsibility.

  • Experience in Pharmaceutical Regulations & Quality Systems (Change Control, Training Systems, Deviations, Supplier Management & Audits & Inspections).

  • Experience at developing & delivering presentations using MS PowerPoint.

  • Preferred: Familiarity with NNPILP processes & systems.

  • Expert knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs for API processes.

  • General knowledge in GMP Manufacturing & Production processes as related to API production.

DESIRED QUALIFICATIONS:

  • Good stakeholder management & change management skills.

  • Strong in setting direction & describe framework.

  • Solid structural & follow up skills.

  • Auditing experience with certification preferred.

  • Excellent written & verbal communication skills.

  • Solid network within PS & related areas within NN or strong Pharmaceutical Industry experience.

  • Good knowledge of Six Sigma or LEAN (cLEAN) principals.

PHYSICAL & OTHER REQUIREMENTS:

  • Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility.

  • Routinely operates & inspects manufacturing equipment using hands.

  • Must be able to be on feet for up to a 12 hour shift.

  • Constantly positions oneself to transfer materials within manufacturing environment. Frequently moves about building(s) to access other personnel & operational areas.

  • Corrected vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license.

  • Occasionally ascends/descends a ladder to access service equipment. Works atop elevated positions at heights.

  • Occasionally required to secure a motorized vehicle license & operate a motorized vehicle.

  • Occasionally works around odorous and/or hazardous materials.

  • Occasionally performs critical job functions in extremely cold work environments.

  • Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment.

  • Able to work in loud noise environments with hearing protection.

  • Able to work in an open office environment with the possibility of frequent distraction.

  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation.

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.

THE SOURCING PERIOD FOR THIS ROLE WILL END 25 JANUARY 2019.



Requisition ID: 59379BR
State/Provinces: Clayton
Job Category: Quality


Please visit our website at www.novonordisk.com

 
 


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