Novo Nordisk US

IT Compliance Analyst - SDF

Novo Nordisk US • $85K — $110K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in IT, Engineering or Automation; Master's preferred
  • Minimum 5 years IT experience in pharmaceutical manufacturing
  • Strong background in software development concepts
  • Proven track record of quality systems and problem-solving
  • Excellent organizational and communication skills
  • Knowledge of FDA computer system regulations
  • In-depth understanding of compliance policies and regulatory requirements

Responsibilities

  • Serve as IT's primary point of contact for compliance matters
  • Analyze and improve IT and automation compliance processes
  • Ensure the availability and capability of IT data systems
  • Develop and implement quality initiatives for customer needs
  • Lead the IT team in audits and manage system validation
  • Coordinate with QA Compliance Specialists for adherence to policies

Benefits

  • Supportive team environment
  • Opportunities for professional development
  • Involvement in diverse project types
  • Potential for cross-departmental collaboration
  • Flexible working conditions with potential travel
Full Job Description
The Position

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.

Relationships

Reports to Manager.

Essential Functions
  • 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
  • Follow all safety and environmental requirements in the performance of duties
  • Other duties 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.)

Qualifications
  • Bachelor's Degree in Information Technology, Engineering or Automation from an accredited university is required. Master's degree in a relevant field preferred
  • Minimum of 5 years of IT experience, with some experience working in a pharmaceutical manufacturing environment required
  • Experience with software development concepts required
  • Proven experience with quality systems & proven problem solving skills required
  • Excellent organizational skills & written/verbal communication skills required
  • Knowledge of FDA regulations & guidelines as they relate to computer-based information systems required
  • 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 required
  • Experience with quality procedures such as non-conformities, change requests & IT system validation required
  • Serve as the liaison between IT & Automation, internal & external QA organizations & other IT auditing organizations required
  • Knowledge of pharmaceutical manufacturing business processes & how IT & automation integrate with them required
  • Excellent troubleshooting skills; ability identify root cause of a problem & assist in determining appropriate IT or technical solutions required
  • Demonstrated skills in identifying & leading medium to large scale IT validation projects required
  • 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 required
  • Provides solutions which are aligned with site strategies & comply with the company's architectural & operating standards & requirements required
  • Experience with developing & maintaining IT-focused policies, procedures & other documents required
  • Experience with HP Application Lifecycle Management software a plus
  • Project management & capital project experience strongly preferred

About Novo Nordisk US

Novo Nordisk is a global healthcare company that specializes in diabetes care and other chronic diseases. The company was founded in Denmark in 1923 and has since expanded to become a leading provider of insulin and other diabetes treatments. Novo Nordisk operates in more than 80 countries and employs over 43,000 people worldwide. The company is committed to improving the lives of people with diabetes and other chronic conditions through innovative research, development, and manufacturing of pharmaceutical products. Novo Nordisk US is headquartered in Plainsboro, New Jersey and has facilities in several other states including North Carolina and New Hampshire.
Learn more about Novo Nordisk US
Size
49,295 employees
Market Cap
$230.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$42.1 billion
Founded
1923
5 Year Trend
+4.7%
Revenue
$126.9 billion
NASDAQ
NVO
* Ladders Estimates

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