Manager, Application Support & Compliance - FFEX

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

Manages a team of professional IT System Managers & Validation Area Specialists, as well as related processes to ensure IT Compliance with regulatory & Novo Nordisk requirements.  Provides leadership & guidance to System Management & IT Validation staff.  Responsible for site System Management & IT Validation staff overseeing computer system validation tasks (New Computer System Validations, Computer System Decommissioning, Investigations/Deviations & associated documentation/testing) & IT System Management tasks (Lifecycle Management). Ensure processes and service level agreements are in place, to include that people are trained sufficiently to meet the business & regulatory requirements.  Responsible for developing strategic goals & objectives in alignment with all relevant NN business plans. Drives improvement projects. Collaborates with Line of Business & Corporate IT Departments.

Relationships

Senior Manager, IT & Automation – FFEx.

Essential Functions

• Develop strategic direction for the company’s IT System Management, Applications & Computer Systems compliance and processes in alignment with Corporate IT strategies & regulatory requirements
• Collaborate with department leadership with oversight of training, development, coaching, performance management, recruitment & employee relations
• Manage, lead & coach teams of Subject Matter Experts (SMEs) to ensure a high performing collaborative team environment.  Provide continuous feedback, structure & accountability to improve team performance
• Drive & Lead System Lifecycle Management, Compliance & Validation teams
• Drive compliance discussions & problem solving to drive lean yet compliant solutions
• Create, develop, define & implement dynamic Key Performance Indicators (KPIs) for areas of responsibility
• Ensure project milestones are met while maintaining compliance
• Actively involve & manage stakeholders at all levels across the organization, as well as in Corporate IT & Business units
• Ensure systems & processes are compliant & meet regulatory & business requirements
• Ensure department is operating in accordance with internal & external regulations & procedures
• 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

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

• BA/BS in Engineering, Computer Science, or applicable technical degree required
• Minimum of seven (7) years of experience in computer systems lifecycle management, validation or quality related discipline experience in pharmaceutical environment required
• Minimum of five (5) years of related experience in stakeholder management & with both exempt & non-exempt employees required
• Minimum of three (3) years of leadership experience required
• Experience in regulatory audits & inspections preferred
• Experience in working with project teams driving deliverables, tasks, & activities for computer system validation preferred
• Understanding of system development lifecycle including validation of computer systems, operation & maintenance & decommissioning of systems preferred
• Understanding of manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities & laboratories) preferred
• Expert in GxP documentation practices & testing strategies preferred
• Proficient in basic computer skills including experience in the use of Microsoft Office preferred
• Ability to independently write protocols & technical documents without supervision preferred
• Excellent oral & written communication skills preferred
• Expert in utilizing appropriate root-cause analysis tools & techniques preferred
• Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams preferred
• Ability to relate well to a wide cross section of stakeholders preferred
• IT Project Management, System Management, & IT Governance preferred
• Demonstrated strong skills in change management within NN preferred

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.