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 office nevironment with the possibility of frequent distractions
• Ability to trael up to 10% of the time (% can chance on a case-by-case basis based on role)

Qualifications

• Bachelor’s degree in science, engineering, business, or relevant field of study from an accredited university required and a minimum of twelve (12) years of experience in pharmaceutical quality, active pharmaceutical ingredient (API) industry, manufacturing or a related area required. 
• Minimum of five (5) years managing other managers required
• Excellent working knowledge of GMP regulations relevant to the business required
• Proven expertise in mentoring/development required
• Excellent written & verbal communication skills required
• Strong presentation skills required
• Proven expertise in mentoring/development, process confirmation, change management, planning/organizing & managing execution required
• Demonstrated ability to review complex organizational plans & provide any required or necessary guidance to ensure success required
• Proven process improvement & problem-solving skills required
• Master’s degree in science, engineering or business field preferred.
• Knowledgeable in systems within pharmaceutical industries to include oral drug production preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.