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 legacy Injectable Finished Products (IFP) 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 IFP, 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 12 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

　　Ensures plant systems batch release & other relevant quality processes are compliant with regulations e.g.: 21CFR part 211. Has product release authority (Authorized Qualified Person), if role is in batch release. Serve as Quality oversight, review & approval of validation activities associated with projects, new systems, changes to existing systems & maintaining validated state of equipment, processes, and systems. Serve as the Finished Product (FP) Process Representative or Site Clayton Process Representative as assigned. Serve as a FP subject matter expert for QA processes & drives improvement activities based on process performance, event response & process confirmation across FP, utilizing LEAN principles.

　　Relationships

　　Senior Manager, Quality Assurance.

　　Essential Functions

　　Make decisions on quality & compliance issues with little guidance

　　Participate in process group activities as assigned & leads local implementations

　　Ensure site compliance with Regulations, ISOISP standards, corporate & local standard operating procedures (SOPs)

　　Serve as the Subject Matter Expert (SME) of the multiple quality processes

　　Lead improvement activities/improvement of standards within the assigned process

　　Lead & coordinates batch release activities

　　Leads large scope tasks that demand project teams & compliance resource management skills

　　Provide coaching to Site regarding quality & compliance related activities

　　Support, review & approve complex cross-functional investigations & root-cause analysis

　　Facilitate sharing of regulatory & compliance expectations

　　Review & approves complex DVs, CRs, SOPs, trend & report data for CAPA, Quality Management Reviews (QMRs) & Annual Product Review (APR) reports

　　Eliminate non-value-added practices

　　Facilitate presentation, support & coaching for audits & inspections

　　Serve as Quality work package owner, or Quality approver of validation documentation

　　Review & approve complex Change Requests (CR's), Deviations(DVs), CAPAs & other documentation

　　Perform Self Audits (in conjunction with line of business (LoB)); QA presence & process confirmation on shop floor

　　Serve as Quality Risk Management Expert and responsible for development and leading and/or facilitating training

　　Follow all safety & environmental requirements in the performance of duties

　　Other accountabilities, as assigned

　　Physical Requirements

　　Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role.

　　Qualifications

　　Bachelor’s degree in Life Sciences, Engineering, or a relevant field of study from an accredited university required

　　Minimum of ten (10) years of QA and/or related quality experience in manufacturing, utility and/or packaging systems required, preferably in the pharmaceutical or medical device field

　　Demonstrated expertise in Regulations & quality systems (e.g., product disposition, Deviations/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, etc.) required

　　Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity preferred

　　Experience with Risk Assessment & Vendor Assessments required

　　Expert in current good manufacturing practice (cGMP) documentation practices. Requires a minimum of 8 years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation preferred

　　Excellent troubleshooting skills: able to identify root cause of problem required

　　Demonstrated knowledge of critical controls & input/output requirements for processes in one or more of the following areas s: product disposition, DV/CAPA, Change Control, semi-finished manufacturing, finished manufacturing, QC, Microbiology/ Environmental Monitoring (EM), IT & process utilities preferred

　　Excellent written & verbal communication skills required

　　Auditing experience with certification preferred (internal/external) required

　　Experience with LEAN, Six Sigma & other continuous improvement methodologies required

　　Expert competence in multiple core validation areas (sterilization, packaging, cleaning, utilities, laboratory methods or equipment, process, or computer system and/or equipment validation) preferred

　　Experience with statistical methods (hypothesis testing, sampling, trending, CpK, etc.) required

　　Expert in utilizing appropriate root-cause analysis tools & techniques preferred

　　Expert in Risk Assessment & Risk Management required

　　For IT-related roles:

　　Knowledgeable in PLC, SCADA, Virtualization/Storage, Active Directory, MES/LMES (Oracle) and/or MS SQL, Knowledge of SAP, PAS-X, and BMS preferred

　　IT audit experience desirable preferred

　　Demonstrated excellence with time management, organizational & project management skills required

　　Expertise in planning/organizing, checking results & revising the work plan for complex problems being resolved by cross functional teams required

　　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.