IT Compliance Analyst - SDF

Benefits

• 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 an individual company match option
• Family Focused Benefits including 14 weeks paid parental leave & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

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
• Comply with internal & external regulations & procedures
• Other duties as assigned

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.)

• 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
• 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 to 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

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

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.