Quality Assurance Area Specialist IV - IT/OT

About the Department You 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 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 . 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 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 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.