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About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 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.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

+ Leading pay and annual performance bonus for all positions

+ All employees enjoy generous paid time off including 14 paid holidays

+ Health Insurance, Dental Insurance, Vision Insurance – effective day one

+ Guaranteed 8% 401K contribution plus individual company match option

+ Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave

+ Free access to Novo Nordisk-marketed pharmaceutical products

+ Tuition Assistance

+ Life & Disability Insurance

+ Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

Design & develop quality & compliance set-up for the Purification, Fermentation, or Recovery process (as appropriate) during the project. Ensure good execution & monitoring according to the FDA's Good Manufacturing Practices (GMP) requirements.

Relationships

Reports to Project Director - Purification, Fermentation or Recovery.

Essential Functions

+ Oversee & approve user requirements for assigned process track

+ Formulate continuous improvement tools for QA Compliance operations

+ Develop Purification, Fermentation or Recovery process (as appropriate) monitoring program & cleaning procedures

+ Ensure compliance with Regulations, ISO standards, & corporate & local SOPs

+ Lead & coordinate Internal & Supplier Audit program

+ Develop & implement 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

+ Perform plant-wide training on Regulations, Quality systems & procedures

+ Coordinate with QA Compliance Specialists regarding tasks to assure compliance with company procedures, policies & objectives

+ Review & approve validation & change control documentation

+ Perform other duties as assigned

+ Execute project

+ Report project performance to the relevant stakeholders

Physical Requirements

May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.

Qualifications

+ Bachelor's Degree in Life Sciences, Engineering, or related field or equivalent combination of education & experience required

+ MA/MS/PhD is preferred

+ 10+ work experience in pharmaceutical manufacturing preferred

+ 8+ years of GMP, QA &/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility preferred

+ 2+ years of supervisory experience preferred

+ Demonstrated expertise in regulations & quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Validation, etc.) preferred

+ Familiarity with processes & quality systems within assigned process track preferred

+ Demonstrated knowledge of critical controls & input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing, & process utilities required

+ Expert knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in biopharmaceutical manufacturing required

+ Excellent written & verbal communication skills required

+ Basic computer skills in MS Office, MS Project, PowerPoint, etc required

+ Auditing experience with certification preferred required

+ Mastery of LEAN tools required

+ Demonstrated excellence in time management, organizational, & project management skills required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. 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.