Quality Management Systems Analyst III

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 457000 square foot aseptic fill and finish site that is responsible for producing innovative injectable diabetes and obesity treatments. At PS AM youll 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 14weeks 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 local quality processes are in compliance with cross-functional requirements as well as regulatory requirements. Accepts ownership of & ensures local quality processes are clearly described in a LEAN manner. Works closely with quality process stakeholders to ensure that the Quality Management System (QMS) functions well within the organization & support quality improvement initiatives.

Relationships

Reports to Manager QSMS.

Essential Functions

• Formulates continuous improvement tools for Quality Management Systems (QMS) operations using LEAN tools & methods
• Ensure site compliance with regulations ISO standards & corporate & local standard operating procedures (SOPs)
• Ensure audits & inspections are managed successfully including locally managed supplier audits
• Develop & implement QMS process improvements
• Provide coaching to the Quality Unit & Site regarding Quality Systems
• Perform plant-wide training on Quality systems & procedures
• Evaluate trends & report data for Deviations Quality Management Reviews (QMRs) Annual Product Reviews (APRs) & other Quality-reports & metrics
• Request & coordinate audits in the Supplier audit program & requests changes of audits in the NNPII (DFP) Audit Client program
• Provide QA oversight for new Supplier/materials maintenance of the Supplier program & discontinuation of supplier/materials including support for Procurement for Manufacturing (PFM) Assists with regulatory-related activities as required
• Perform self-audits and monitor quality trends
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)

Qualifications

• High School Diploma or equivalent (GED) required
• Bachelors degree in Engineering Computer Science or a relevant field of study from an accredited university preferred
• Minimum of six (6) years of QA and/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility required
• Experience in Pharmaceutical Regulations & Quality Systems (e.g. Change Control Training Systems Handling of Deviations Annual Product Review Quality
• Management Review Audits & Inspections Regulatory Reporting etc.) preferred
• Familiarity with NNPILP local processes & quality systems preferred
• Experience at developing & delivering presentations using MS Office software preferred
• Expert knowledge of US EU regulations & guidelines ISO standards & application of GMPs in aseptic manufacturing preferred
• Excellent written & verbal communication skills required
• Excellent computer skills in MS Office required
• Ability to trend analyze & report data (i.e. Excel) required
• Good understanding & skilled use of LEAN tools (i.e. Define-Investigate-Conceptualize-Optimize-Build (DICOB) Systematic Problem Solving (SPS) etc.) 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 were 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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.