US-NC, GMP Partner - API Job 383320100A2-MZ
|Requisition ID 44170BR|
Title GMP Partner - 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.
* Design & develop quality & compliance set-up for the Recovery process during the project.
* Ensure good execution & monitoring according to the FDA’s Good Manufacturing Practices (GMP) requirements.
* 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.
* Per assigned process track
* BA/BS in Life Sciences, Engineering, or related field or equivalent combination of education & experience. Mandatory
* MA/MS/PhD is preferred.
* 10+ work experience in pharmaceutical manufacturing.
* 8+ years of GMP, QA &/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
* 2+ years of supervisory experience.
* Demonstrated expertise in regulations & quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Validation, etc.).
* Familiarity with processes & quality systems within assigned process track.
* Familiarity of processes & quality systems within assigned process track.
Technical/Process/Functional Knowledge: Mandatory
* Demonstrated knowledge of critical controls & input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing, & process utilities.
* Expert knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in biopharmaceutical manufacturing.
* Excellent written & verbal communication skills.
* Basic computer skills in MS Office, MS Project, PowerPoint, etc.
* Auditing experience with certification preferred.
* Mastery of LEAN tools.
Organization/Planning: Demonstrated excellence in time management, organizational, & project management skills. Mandatory
Physical & Other Requirements:
* Ability to work in & around an active construction site during project phase.
* Ability to move throughout the facility in the performance of duties in proximity of process equipment & areas.
* Ability to work hours necessary & according to process needs.
Department DAPI US - Fermentation
Position Location US - Clayton, NC
State/Provinces US - NC
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