Director, Quality Assurance

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our 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 Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

 

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 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

 

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

Oversee the two NNPILP Emerging Technologies (ET) sites, which includes responsibility for the Quality Assurance (QA) function and serving as the leading expert in quality, compliance, quality management systems (QMS) & regulatory affairs.  Provide direction & coordinating the activities of the Quality organization to support the business progress, formulating, communicating & implementing QA strategy that effectively supports the manufacturing of products.  Coordinate with the leadership team & other relevant stakeholders to ensure strong communication & working with relevant members of leadership team to ensure aligned priorities on short/medium/long range.

Relationships

Vice President

Essential Functions

• Serve as key partner for site leadership, managing business integration & site strategy to support manufacturing of product through testing and quality programs to ensure product safety and quality
• Serve as the US Authorized Person, responsible for ensuring compliance with all regulatory requirements and maintaining the highest standards of quality assurance within the organization
• Participate as member of Quality Leadership Team in setting quality goals, objectives & policies, which includes ensuring the quality goals align to the respective site’s goals
• Meet or exceed business, regulatory & customer requirements in accordance with Novo Nordisk Way
• Provide expertise on Good Pharmacovigilance, Manufacturing, Distribution and Clinical practice compliance issues and actions
• Ensure technical training & development on Quality Management is in place across the business
• Direct, coach & manage quality management team, which includes but is not limited to training & development, performance management/review & development planning, talent recruitment/selection, managing employee relations, overseeing financial matters and driving continuous process improvement & projects
• Maintain effective communication, collaboration & alignment across stakeholders, site management & global sites
  Ensures coordination and oversight of internal audits and external inspections at NN ET (i.e. FDA or any other external healthcare related inspection)
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities as assigned

Physical Requirements

• Abilitty to work in an open