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Novo Nordisk
Project Quality Assurance Validation Lead - Warehouse/IntralogisticsNovo Nordisk • Clayton, North Carolina , United States
Project Quality Assurance Validation Lead - Warehouse/Intralogistics

Project Quality Assurance Validation Lead - Warehouse/Intralogistics

Novo Nordisk • Clayton, North Carolina , United States
10 days ago
Job type
  • Full-time
Job description
About the DepartmentYou will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20, of Novo Nordisk’s 50, employees. FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world. 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% K 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 PositionValidation Lead (Project Quality) for IFP expansion projects. Provides comprehensive validation subject matter expertise (i.e., equipment, facility, cleaning, sterilization, product, process validation). Builds detailed knowledge of the Novo Nordisk validation procedures/validation manual & directs project areas in developing compliant validation strategies. RelationshipsReports to Senior Project Manager, Site Capacity & Upfit. Essential FunctionsBuild Subject Matter Expert (SME) understanding of the Novo Nordisk science & risk-based validation proceduresProvide SME level knowledge to project groupsLeads the development of all electronic validation structureIdentify & implement lean project execution activitiesTranslate procedural requirements within the validation area into practical workflows guiding the project executionIdentify & implement improvements that support lean project executionBuild strong cross-functional relations with Novo Nordisk project organization & validation project contributors (local & abroad)Other accountabilities, as assigned. Physical RequirementsMay 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 colour vision based on role. May require the ability to work in loud noise environments with hearing protections. QualificationsBachelor's Degree in pharmaceutical, engineering, or other technical science field or equivalent combination of education & experience requiredMA/MS degree in pharmaceutical, engineering, or other technical science field or equivalent combination of education & experience preferredMinimum of eight years of equipment & facilities validation experience preferredSME experience from pharma production environment preferredPreferred knowledge of Novo Nordisk science & risk-based validation procedures preferredProven experience with quality systems preferably within pharma industry preferredExperienced in the development, implementation, validation &/or maintenance of equipment & facilities in the pharmaceutical/medical device manufacturing, laboratory, or business environment preferredProject execution experience, preferably in a Novo Nordisk context, as supplier or internal SME preferredUnderstanding of lean project execution principles, continuous improvements & application in a small & large-scale project environment preferredSolid project execution experience & the ability to link/translate validation procedures & principles to practical hands-on project work processes preferredExperience in working with external engineering consultants & ensuring integration of NN quality requirements preferredFamiliar with LEAN & continuous improvement methodologies preferredWritten & verbal communication skills to allow interaction with all levels of operations & management preferredProven expertise in project management, in planning/organization, &/or project execution preferredFollow-up & completion preferredSME level skills within validation & the links to project execution planning preferred We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today. 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.
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Project Quality Assurance Validation Lead - Warehouse/Intralogistics • Clayton, North Carolina , United States

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