Requisition ID 43171BR<br/>Title Project Quality Validation Lead<br/>Job Category Quality<br/>Job Description Your Groundbreaking Journey:<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/>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:<br/>* Validation Lead (Project Quality) within the DAPI-US Project.<br/>* Provides subject matter expertise within the area of equipment & facility validation.<br/>* Builds detailed knowledge of the Novo Nordisk validation procedures/validation manual & directs project areas in how to perform validation steps.<br/><br/>Education:<br/>BA/BS within IT, CIS, MIS, engineering or other technical science field. Mandatory<br/>MA/MS preferred.<br/><br/>Experience:<br/>* 8+ years of equipment & facilities validation experience.<br/>* SME experience from pharma production environment. Preferred knowledge of Novo Nordisk validation procedures, quality & validation manuals.<br/>* Proven experience with quality systems preferably within pharma industry.<br/>* Experienced in the development, implementation, validation &/or maintenance of IT systems in the pharmaceutical/medical device manufacturing, laboratory, or business environment.<br/>* Project execution experience, preferably in a Novo Nordisk context, as supplier or internal SME.<br/>* Understanding of lean project execution principles, continuous improvements & application in a large-scale project environment.<br/><br/>Technical/Process/Functional Knowledge:<br/>* Solid project execution experience & the ability to link/translate validation procedures & principles to practical hands on project work processes.<br/>* Experience in working with external engineering consultants & ensuring integration of NN quality requirements.<br/>* Familiar with LEAN, Six Sigma, & continuous improvement methodologies.<br/>* Written & verbal communication skills to allow interaction with all levels of operations & management.<br/><br/>Organization/Planning: Mandatory<br/>* Proven expertise in project management, in planning/organization & project execution.<br/>* Follow-up & completion.<br/>* SME level skills within validation & the links to project execution planning.<br/><br/>Physical & Other Requirements:<br/>* Ability to work in & around an active construction site during project phase.<br/>* Ability to work in confined spaces & near operating equipment.<br/>* Ability to work in loud noise environments.<br/>* Ability to travel locally and internationally as necessary.<br/>* Ability to work flexible hours to support international delivery team.<br/><br/>Additional Information Accountabilities:<br/>* Write & approve various quality planning documents.<br/>* Build Subject Matter Expert (SME) understanding of the Novo Nordisk validation procedures.<br/>* Make SME level knowledge available to project groups.<br/>* Hands on execution of various quality planning documents from high level project quality management plan to detailed process specific workflows.<br/>* Identify & implement lean project execution activities.<br/>* Plan, participate & follow up on supplier audits.<br/>* Translate procedural requirements within the validation area into practical workflows guiding the project execution.<br/>* Identify & implement improvements that support lean project execution.<br/>* Build strong cross-functional relations with Novo Nordisk project organization & the supplier landscape (engineering, equipment vendors, contractors, etc.).<br/><br/>Department DAPI US - Project Quality<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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