Vice President, Quality Control

Location

Clayton, NC | United States

Job description

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

Lead the Quality Control organization to support the production of Novo Nordisk products & devices through testing programs which meet or exceed business, regulatory & customer requirements, in accordance with the Novo Nordisk Way. Direct and coordinate activities of Quality Control and provide overall responsibility for Chemistry, Microbiology, Physical Testing & Raw Material testing, equipment, personnel, facilities & budget, to include supporting analysis of samples for the NNPILP Production Sites and related Contract Manufacturers.

Relationships

Corporate Vice President IFP and coordination with CVP API, VP OFP and CVP ManDev.

Essential Functions

• Lead the strategic and tactical activities for Quality Control for the NNPILP sites
• Manage areas of accountability via subordinate management by setting direction, following up to ensure progress and goal attainment, and to provide feedback and coaching. A high level of innovation and collaboration is expected to continuously improve QC processes and achieve improved quality
• Overview daily operations of Quality Control organizations; lead, guide and coach a team of directors and managers, ensure a healthy and engaged working environment
• Responsible for participation in setting plant goals, objectives, policy & continuous improvement projects as a member of the Senior Leadership Team (SLT)
• Ensure accuracy & scientific soundness of QC Laboratory data
• Ensure GMP compliance of QC laboratories
• Oversee LIMS systems management to include associated process improvements
• Ensure timeliness of laboratory results to meet batch release KPIs
• Oversee lab equipment & facilities
• Contribute to GMP compliance of site
• Identify needs and opportunities for overall strategic changes in the culture and organization or in the way by which the business is positioned
• Manage weekly process confirmation of areas to ensure compliance with local & global standards
• Work with complex issues that require broad-based sustainable solutions involving other functions across NN
• Oversee critical investigations (e.g., failure/CAPA) to ensure that these result in thorough root cause analysis & implementation of effective preventive actions
• Ensure method revalidations & transfers meet regulatory expectations & requirements
• Set long and short-term business strategies and plans; oversee implementation
• Set financial goals, prepare, and allocate resources, identify ways to increase revenue and decrease costs within their area of responsibility
• Maintain awareness of competitors, markets, best practices, and new industry standards and development
• 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.

Development of People

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 Chemistry, Microbiology or or a relevant field of study from an accredited university required; Master’s degree preferred
• Minimum of twelve (12) years of quality experience in the pharmaceutical industry required; preferably with laboratory experience, such as Sterile Product Quality Assurance, with a demonstrable knowledge base in Sterile Product cGMPs & knowledge of API Production
• Minimum of ten (10) years of leadership experience required
• Minimum of five (5) years of managing other managers experience required, preferably in a pharmaceutical manufacturing environment
• Experience with method validation and/or method transfer preferred
• Working knowledge of GMPs & compendia requirements (USP/EP/JP) required
• Able to orchestrate large scale win-win situations in complex stakeholder landscapes required
• Demonstrated ability to present technical & scientific information to others required
• Proven track record of creating business results with impact within several SVP areas required
• Demonstrated ability in strategy-building and implementation 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.

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