Associate Manager, QA Aseptic Production (Onsite)

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 Aseptic Production (QA AP) team in accordance with the Novo Nordisk Way. Ensures plant systems are compliant with applicable regulations. Works closely with manufacturing to improve quality of the product & production processes. Collaborates with stakeholders.

Relationships

Reports to Senior (Sr.) Manager, QA Aseptic Production.

Essential Functions

• Lead & coach continuous improvement activities within the QA AP operations
• Ensure site compliance with relevant Current Good Manufacturing Practices (cGMPs) & corporate/local standard operating procedures (SOPs)
• Lead & coordinate batch release activities to meet KPI & customer requirements
• Develop & implement metrics for Quality System process improvements
• Coach & develop QA AP team members
• Proven ability to motivate & lead people
• Ensure that Key Performance Indicators (KPIs) are defined & measured
• Support/coach Systematic Problem Solving (i.e. continuous improvement & investigations)
• Approve deviations and change requests as required
• Timeliness of batch release processes to meet batch release KPIs
• Effective stakeholder collaboration & shop floor presence
• Perform Process Confirmations of Batch Release activities
• Ensure direct reports have individual development plans (IDP), to include setting annual goals and measurements that are consistent with business priorities and conduct interim employee reviews so their work remains aligned on the priorities and they understand their level of accountability for achieving the outlined results based on the defined measurements
• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way
• 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 relevant field of study from an accredited university required
• Minimum of five (5) years of QA or manufacturing experience in the pharmaceutical or medical device industry with progressively increasing responsibility required
• Minimum of three (3) years of direct supervisory experience preferred
• Demonstrated expertise in quality systems (e.g. product disposition, deviations, quality monitoring, change control, audits/inspections, validation, quality risk management, etc.) required
• Experience leading or managing projects preferred
• Demonstrated knowledge of aseptic production of parenteral products & associated process utilities preferred
• Working knowledge of US, EU regulations & guidelines, & application of GMP’s in aseptic manufacturing preferred
• Knowledge of QA Processes (i.e. Change Control, CAPA, Deviation Handling, Validation, etc.) required
• Certified 4P Trainer required
• Demonstrated leadership skill & competencies preferred
• Excellent written & oral communication skills required
• Workload balancing required
• Basic computer skills in MS Office, MS Project, etc. required
• Ability to work day or evening shifts preferred
• Knowledge of LEAN tools required
• Strong computer skills required
• Demonstrated excellence of time management, organizational, & project management skills 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.