Associate Director, Quality Assurance Support

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 help improve the quality of life for millions of people around the world. In North Carolina, we operate three pharmaceutical manufacturing facilities 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 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.

Responsibilities

• Lead the QA Support department according to PS Leadership competencies, 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
• Drive high performance & employee engagement
• Contribute to the site Quality Management team by participating in strategy development
• Ensure robust processes are in place to exceed all quality objectives & requirements
• Champion Continuous Improvement processes in the team
• Promote positive collaboration with internal & external stakeholders
• Participate in regulatory inspections & internal audits
• Serve as backup for Vice President of Quality
• Other accountabilities, as assigned

Development of People

• Supervisory responsibilities include ensuring reporting personnel have individual development plans (IDP) with annual goals and measurements aligned with business priorities, and that interim reviews are conducted.
• Ensure IDP forms include completed learning and aspiration plans for all reporting personnel to enable goal achievement and capability to assume increased responsibility.
• Manage the application and communication of all Novo Nordisk policies, procedures, and the Novo Nordisk Way.

Requirements

• 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 (e.g., ICH Q10) preferred
• Excellent written & oral communication skills preferred
• Exercises good judgment in decision-making 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

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 (percentage may vary based on role)

Benefits

• Leading pay and annual performance bonus for all positions
• Generous paid time off including 14 paid holidays
• Health, Dental, and 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