(Associate) Manager, Quality Control Instrumentation & Validation Support

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 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 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

Responsible for supervising the validation, maintenance and calibration program for QC laboratory instrumentation. Ensures timely execution of the validation, preventative maintenance, unscheduled maintenance, and calibration of laboratory instrumentation with a strong customer service mindset.  The QC department operates on a Monday - Thursday schedule, 10hr day shift schedule. 

Relationships

Sr Manager.

Essential Functions

• Ensure QC validation, equipment maintenance and calibration program is executed timely
• Coordinate with the responsible manager and other teams to support laboratory equipment
• Content owner for laboratory maintenance and calibration documents
• Ensures service contracts are established and maintained for maintenance and calibration, to include partnering with external vendors
• Serve as point of contact for stakeholders and work in a collaborative manner with parties within QC and outside QC
• Ensures proper resources are available to maintain high uptime of equipment
• Support training planning and development of maintenance and calibration personnel
• Ensure quality items and project deliverables are completed timely
• Facilitate problem solving, investigations, and process improvements
• Responsible for ensuring laboratory areas are inspection ready
• Responsible for supervising their team to include performance management, coaching, development, engagement, and annual merit review
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities, as assigned

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.

Development of People

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.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a relevant field of study from an accredited university required
• May consider associate’s degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university with a minimum of five (5) years of experience in a manufacturing organization required; preferably pharmaceutical manufacturing
• Minimum of three (3) years of experience in a manufacturing organization required, preferably pharmaceutical manufacturing
• Minimum of three (3) years of supervisory experience required
• May consider three years of team lead experience driving the day-to-day actions and establishing work schedules for the team(s), etc.
• Demonstrated knowledge in SAP and LIMS preferred
• Experience working in quality systems (e.g., deviations, change control, audits/inspections, validation, etc.) required
• Strong organizational skills and ability to create and maintain job duties for direct reports required
• Demonstrated knowledge of QC equipment instruments, maintenance and calibration required
• Ability to flex to cover weekends for emergent maintenance issues, as 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, we’re 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.