IT Compliance Analyst - API Job Job in North Carolina (NC), Career, Full Time Jobs in Novo Nordisk Inc.
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IT Compliance Analyst - API Job job in Clayton

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Novo Nordisk Inc. jobs
North Carolina (NC), Clayton
Job Code:  58746BR
Employer:  Novo Nordisk Inc.
Job Type:  Full Time

Country:  United States
State:  North Carolina (NC)
City:  Clayton

Your Groundbreaking Journey
At Novo Nordisk, we want to make a difference. For more than 90 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 and improve the quality of life for millions of people around the world.

To help meet the growing demand for our diabetes treatment, Novo Nordisk expects to double production of diabetes drugs over the next decade. Novo Nordisk is currently building a new diabetes API plant in Clayton, NC next to our existing facility that employs 800 people. The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.

Novo Nordisk is currently seeking top talent for this green field project and eventual operations. This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build. Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.

Serve as IT's primary point of contact & subject matter expert (SME) on all IT related compliance policies & programs. Assist with the development & execution of key IT projects.

  • Improve our capability to provide quality to all IT & automation processes by analyzing & improving the levels of compliance (Project management, Quality programs).
  • Ensure IT data systems are available, capable & accessible so that IT systems operate at the speed of business processes through quality initiatives & projects (ARE Management, business continuity & IT support).
  • Recommend & implement quality initiatives to meet the customer's needs, regulatory & internal compliance & add value to all business processes.
  • Become subject-matter expert (SME) with NN validation software, eTIMs, within the IT team.
  • Project management - develop & utilize skills necessary to develop, manage & implement IT projects of all sizes (small to large scale projects).
  • Follow all safety & environmental requirements in the performance of duties.
  • Manage change requests & system validation for IT.
  • Serve as IT lead for audits.
  • Coordinate with QA Compliance Specialists to assure compliance with procedures & policies.
  • Support & practice IT Security.
  • Follow all safety & environmental requirements in the performance of duties.
  • Comply with internal & external regulations & procedures.
  • Other accountabilities as assigned.

  • Minimum of 5 years of IT experience, with some experience working in a pharmaceutical manufacturing environment.
  • BA/BS in Information Technology, Engineering or Automation (MA/MS in relevant field preferred).
  • Experience with software development concepts.
  • Proven experience with quality systems & proven problem solving skills.
  • Excellent organizational skills & written/verbal communication skills.
  • Knowledge of FDA regulations & guidelines as they relate to computer-based information systems.
  • In-depth knowledge & training on compliance policies, programs & procedures as well as regulatory requirements, such as 21 CFR Part 11, electronic records retention, configuration items lists, revalidation, etc.
  • Experience with quality procedures such as non-conformities, change requests & IT system validation.
  • Serve as the liaison between IT & Automation, internal & external QA organizations & other IT auditing organizations.
  • Knowledge of pharmaceutical manufacturing business processes & how IT & automation integrate with them.
  • Excellent troubleshooting skills; ability identify root cause of a problem & assist in determining appropriate IT or technical solutions.
  • Demonstrated skills in identifying & leading medium to large scale IT validation projects.
  • Possesses & applies a broad range of expertise of principles, methods, practices, standards, procedures & compliance requirements of a particular business function in designing & developing complex IT solutions.
  • Provides solutions which are aligned with site strategies & comply with the company's architectural & operating standards & requirements.
  • Experience with developing & maintaining IT-focused policies, procedures & other documents.
  • Experience with HP Application Lifecycle Management software.
  • Occasionally moves equipment and/or supplies weighing up to 30 pounds within the facility.
  • Constantly operates a computer & other office equipment using hands.
  • Able to travel internationally, up to 10% of the time.
  • 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.

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: 58746BR
State/Provinces: Clayton
Job Category: Information Technology

ref: (58746BR)
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