Associate Director, Quality Assurance

Associate Director, Quality Assurance Support

Facility:
Quality

Location:

Clayton, NC, US

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 employees to embark on 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.

• 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

Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

Responsible for leading the QA Support department to ensure fulfillment of departmental targets in accordance with the Novo Nordisk Way while maintaining compliance with applicable regulations & SOPs. Leads initiatives to drive process improvements within respective department.

Reports to Vice President, Quality Assurance.

• Responsible for leading the QA Support department according to PS Leadership competences, including:
  • Maintaining compliance with applicable regulations & procedures
  • Target setting & follow-up (performance management)
  • Prioritization of tasks
  • Improvement of productivity through efficient processes
  • Development of employees
  • Effectively lead through others as a second-line leader
  • Driving high performance & employee engagement
  • Contributing to the site Quality Management team by participation in strategy development
  • Ensuring robust processes are in place to exceed all quality objectives & requirements
  • Championing Continuous Improvement processes in the team
  • Promoting positive collaboration with internal & external stakeholders
  • Participation in regulatory inspections & internal audits
  • Backup for Vice President of Quality
• Other accountabilities, as assigned

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.)

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

• Bachelor's Degree in Life Sciences, Engineering or related field required
• Minimum of seven (7) years of leadership (direct or indirect) experience.
• Minimum of eight (8) years of experience in the pharmaceutical industry, preferably with experience in finished production processes of devices and combination products
• Demonstrated expertise & knowledge of US, EU regulations & guidelines, & application of GMP’s preferred
• Demonstrated knowledge of Pharmaceutical Quality Systems (i.e. ICH Q10) preferred
• CQA, CMQ/OE, &/or CQE certification preferred
• Demonstrated knowledge of cLEAN® preferred
• Proven expertise in mentoring & development, change management, planning & organizing, managing execution, & revising work plans for complex issues addressed by cross‑functional teams required

At Novo Nordisk, we’re 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.