IT Compliance Analyst - SDF

Novo Nordisk • Durham, NC

7h • Onsite

About 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. 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.

Requirements

• Bachelor's Degree in Information Technology, Engineering or Automation from an accredited university is required.
• 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.

Nice To Haves

• Master’s degree in a relevant field preferred.
• Experience with HP Application Lifecycle Management software a plus.
• Project management & capital project experience strongly preferred.

Responsibilities

• 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.

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 individual company match option
• Family Focused Benefits including 14 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior