Prabhdeep Singh

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Supervisor, IT System Mgmt & Validation Job

Date: May 10, 2019

Location: Clayton, NC, US

Company: Novo Nordisk

At Novo Nordisk, we want to make a difference. For more than 95 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.

Help us bring quality to life. We are currently seeking top talent for our two pharmaceutical manufacturing facilities in Clayton, NC.

Working at our fill/finish facility (DFP)

Make What Matters
Our 457,000 square foot aseptic “fill and finish” manufacturing facility in Clayton, NC, currently employs more than 850 people. The facility is part of a global network of manufacturing sites responsible for several key steps in the diabetes treatment manufacturing process, including sterile formulation, filling, inspection, device assembly and packaging. Producing medicines is a special responsibility. Our employees are passionate about what they do, knowing that their work makes a difference to millions of people who rely on our products every day. Join us and help make what matters.

Position Purpose:
Manages NNPILP Site Clayton DFP 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’s 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, service level agreements are in place & people are trained sufficiently to meet the business & regulatory requirements. Responsible for developing strategic goals & objectives in alignment with all relevant NN business plans. Drive improvement projects. Collaborate with Line of Business & Corporate IT Departments.

  • Develop strategic direction for the company’s IT System Management & Computer System Validation 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 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.

Required Education:

BA/BS in Engineering, Computer Science, or applicable technical degree.

Required Experience:
  • Minimum of seven (7) years of experience in computer system validation or quality related discipline experience in pharmaceutical environment.
  • Minimum of five (5) years of related experience in stakeholder management & with both professional & hourly employees.

Desired Experience:
  • Demonstrated leadership capabilities & experience desired.
  • Experience in regulatory audits & inspections.
  • Experience in working with project teams driving deliverables, tasks, & activities for computer system validation.

Technical/Process/Functional Knowledge:
  • Knowledgeable in the following areas:
    • Understanding of system development lifecycle including validation of computer systems, operation & maintenance & decommissioning of systems.
    • Understanding of manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities & laboratories).
    • Expert in GxP documentation practices & testing strategies.
  • Proficient in basic computer skills including experience in the use of Microsoft Office.
  • Ability to independently write protocols & technical documents without supervision.
  • Excellent oral & written communication skills.
  • Expert in utilizing appropriate root-cause analysis tools & techniques.

  • Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams.
  • Ability to relate well to a wide cross section of stakeholders.
  • IT Project Management, System Management, & IT Governance
  • Demonstrated strong skills in change management within NN.

Physical and other Requirements:
  • Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions.
  • Constantly operates a computer & other office equipment using hands.
  • Able to work in an open office environment with the possibility of frequent distraction.
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation.
  • Able to adjust schedule to work with colleagues in other international time zones.
  • Able to travel internationally, up to 30% of the time.

Life-Changing Careers with Novo Nordisk
With a local presence for more than 25 years, Novo Nordisk is one of the largest employers in Johnston County, with over 1,200 highly-skilled and dedicated employees working in Clayton and a diverse, global workforce of more than 40,000.

We aspire to operate in a socially responsible way, and we are committed to offering a healthy and engaging workplace. Our Clayton manufacturing facilities have been honored as a FORTUNE 100 Best Places to Work For 10 years in a row. Other recent employer honors include the ISPE Company of the Year, the Triangle Business Journal Healthiest Employers in the Triangle and the NC Department of Labor 2 Million Hour Safety Award. Approximately 19% of our Clayton employees are veterans, and we offer year-round opportunities to give back to the community.

If you’re looking for a life-changing career with real impact, join our team and help us defeat diabetes, obesity and other chronic diseases.

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

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.

Requisition ID: 59870BR
State/Provinces: Clayton
Job Category: Information Technology

Nearest Major Market: Raleigh

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