Associate Manager, 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 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 legacy Injectable Finished Products (IFP) 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 IFP, you’ll join a global network of manufacturing professionals who are passionate about what they do.

 

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 12 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

Supervises Quality Assurance (QA) personnel assigned to a QA team in accordance with the Novo Nordisk Way. Ensures plant systems are compliant with applicable regulations.  Works closely with stakeholders to improve quality of the product & production processes. Collaborates with stakeholders. Ensures achievement of the Novo Nordisk Quality Mission to deliver the highest quality to patients by striving for simplicity, ensuring compliance, being at the forefront, and accepting responsibility.

 

Relationships

Reports to Senior (Sr.) Manager.

 

Essential Functions

• Lead & coach continuous improvement activities within the QA
• Ensure site compliance with relevant cGMPs & corporate/local SOPs that leads to successful assessments, audits and/or inspections
• Lead & coordinate batch release activities to meet KPI & stakeholder requirements
• Develop & implement metrics for Quality System process improvements
• Coach & develop QA team members
• Motivate & lead people
• Ensure that KPIs are defined & measured
• Support/Coach Systematic Problem Solving (i.e., hierarchy of controls, continuous improvement & investigations)
• Approve Deviations and Validation defects as required
• Identify, assess, mitigate, and report Quality risks
• Consult, inform, & collaborate with both local & global stakeholders
• Meet pre-defined timelines by working with real-time data and predictive analytics to drive performance
• Perform Quality Oversight & Process Confirmation activities
• Knowledge of QA Management Systems (i.e., Change Control, Validation, etc.)
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

 

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. (% can change on a case by case basis based on the role.

 

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 related field of study from an accredited university required
• Minimum of five (5) years of QA, validation or laboratory experience in the pharmaceutical or medical device industry, with progressively increasing responsibility required
• Minimum of three (3) years leadership experience required
• Demonstrated