Requisition ID 44493BR<br/>Title Sr QA Area Specialist II - Raw Mat<br/>Job Category Quality<br/>Job Description Your Groundbreaking Journey<br/><br/>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.<br/><br/>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.<br/><br/>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.<br/><br/>Position Purpose: Design & develop quality & compliance set-up for global systems that interface with Raw Materials Warehouse testing for the DAPI-US project. Train personnel for equipment & systems work package in relevant quality related issues. Ensure compliant execution & monitoring. Drive corrective actions & quality improvement initiatives within QC Raw Materials. Develop QA based work package for QC Raw Materials testing. Assist with transfer of knowledge base from Denmark based sites to DAPI-US site.<br/><br/>Accountabilities:<br/>Novo Nordisk Way SME for implementation of Raw Materials testing program in DAPI-US.<br/>Oversee & approve user requirements for assigned process.<br/>Formulate continuous improvement tools for QA compliance operations.<br/>Develop assigned process monitoring program & cleaning procedures.<br/>Ensure compliance with regulations, ISO standards, & corporate & local SOPs.<br/>Lead & coordinate Internal & Supplier Audit program.<br/>Develop & implement metrics for Quality System process improvements.<br/>Provide coaching to QA Compliance & Site regarding quality-related activities.<br/>Prepare & approve documents regarding QA department related activities.<br/>Support, review & approve complex cross-functional investigations & root-cause analysis.<br/>Perform plant-wide training on regulations, Quality systems & procedures.<br/>Coordinate tasks of QA Compliance Specialists to assure compliance with company procedures, policies & objectives.<br/>Review & approve validation & change control documentation.<br/>Execute project(s) to meet critical timelines.<br/>Ensure quality & compliance in QA for QC Raw Materials area.<br/>Report project performance to the relevant stakeholders.<br/>Train DAPI-US site personnel on Raw Materials procedures.<br/>Perform other duties as assigned.<br/>Must travel to Denmark for a period of 6 months to 12 months and have a valid passport<br/><br/>Education:<br/>BA/BS in Chemistry, Pharmacy, Microbiology, or similar field; MA/MS preferred.<br/><br/>Experience:<br/>8+ years, minimum 5 years of experience from operating in, or project management experience in, a GMP regulated environment.<br/><br/>Technical/Process/Functional Knowledge:<br/>Expert knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs within Automation.<br/>Solid network within Product Supply (PS) & related areas within NN or strong pharmaceutical industry experience.<br/>Good knowledge of Six Sigma or LEAN (cLEAN®) principles.<br/>Auditing experience with certification preferred.<br/>Quality Management System (QMS) experience in the pharmaceutical/biotech industry.<br/><br/>Physical & Other Requirements:<br/>Ability to work in & around an active construction site during project phase.<br/>Ability to move throughout the facility in the performance of duties in proximity of process equipment & areas.<br/>Ability to work hours necessary & according to process needs.<br/>Must be able to work internationally (DK) during first 6-12 months & thereafter on an “as needed” basis.<br/><br/>Department DAPI US - QA<br/>Position Location US - Clayton, NC<br/>City Clayton<br/>State/Provinces US - NC
<br/><br/>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
<br/><br/>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!
<br/><br/><p class="eeo_desc">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.<br/><br/>
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.<br/><br/>
If you are interested in applying for employment with Novo Nordisk and need special assistance or an accommodation to use our website or to apply for a position, please call the U.S. Toll Free number at 1-855-411-5290 or click on the following link to submit your request: <a href="https://www.surveymonkey.com/r/novoaccommodation" target="_blank" title="Accomodation Survey">https://www.surveymonkey.com/r/novoaccommodation</a>. Please note we do not accept applications for employment or employment related solicitations through this site. If you are requesting special assistance, please specify your request by selecting "Yes" in Question 2 on the site. We will not be able to respond to requests unless you specify the need for special assistance or an accommodation in Question 2. Determinations on requests for reasonable accommodation are made on a case-by-case basis.</p>
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