About the Department At Novo Nordisk, we want to make a difference. 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 Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, 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 Develop & maintain quality & compliance processes for QC Site Clayton. Ensure high level of compliance according to NN & GMP requirements. Relationships Reports to Director, QC & EM. Essential Functions + Ensure compliance with Regulations, ISO standards, & corporate / local SOPs + Coordinate tasks with QA & LoB to ensure compliance with company procedures, policies, & objectives + Prepare change control & other QMS documents for QC Site Clayton + Develop metrics & analyze trends for Quality System process improvements, SPS, deviations, & CAPA + Create & execute continuous improvement tools for Quality & Compliance operations to drive performance + Provide coaching & guidance regarding quality-related activities. Train & support users in the Quality Management Systems + Represent QC in internal audits & inspection for general lab processes & compliance topics + Development of long-term process & quality improvement plans for Site Clayton QC + Champion creation of simple & robust Quality standards & expectations + Drive quality process performance to meet business & customer needs + Championing the Quality Mindset & Event Communication + Identify trends proactively to drive & prioritize compliance improvement projects & initiatives + Execute & support site-wide cross-functional investigations, systematic problem-solving & process improvements + Initiate & support compliance-related process confirmations & Go-Look-Sees + Create proactive department efforts in identifying preventive actions to eliminate compliance gaps + Establish, monitor & process-confirm internal department compliance plans & self-audit / inspection readiness processes + Perform other duties, as assigned 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 preferred + 10+ years of work experience in pharmaceutical manufacturing required + 8+ years of GMP, QA and/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility required + Demonstrated expertise in regulations & quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Validation, etc.) preferred + Demonstrated knowledge of NN processes & quality systems required + Demonstrates knowledge of adult learning methodologies & is able to use multiple methods to train & coach others preferred + Expert knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in biopharmaceutical manufacturing preferred + Excellent written & verbal communication skills preferred + High level of proficiency in MS Office, MS Project, PowerPoint, etc preferred. + Auditing experience with certification preferred required + Demonstrates experience in data analysis problem-solving & process improvement methods preferred + Mastery of LEAN tools required + Demonstrates excellence in time management, organizational & project management skills preferred 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.