IT Compliance Analyst - SDF

Position

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

Reports to Manager.

• Improve our capability to provide quality to all IT and automation processes by analyzing and improving levels of compliance (Project management, Quality programs)
• Ensure IT data systems are available, capable, and accessible so that IT systems operate at the speed of business processes through quality initiatives and projects (ARE Management, business continuity and IT support)
• Recommend and implement quality initiatives to meet the customer’s needs, regulatory and internal compliance, and add value to all business processes
• Become subject‑matter expert (SME) with NN validation software, eTIMs, within the IT team
• Project management – develop and utilize skills necessary to develop, manage, and implement IT projects of all sizes (small to large scale projects)
• Follow all safety and environmental requirements in the performance of duties
• Manage change requests and system validation for IT
• Serve as IT lead for audits
• Coordinate with QA Compliance Specialists to assure compliance with procedures and policies
• Support and practice IT Security
• Comply with internal and external regulations and 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. (Percentage 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 and proven problem‑solving skills required.
• Excellent organizational skills and written/verbal communication skills required.
• Knowledge of FDA regulations and guidelines as they relate to computer‑based information systems required.
• In‑depth knowledge and training on compliance policies, programs, and 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, and IT system validation required.
• Serve as the liaison between IT and Automation, internal and external QA organizations and other IT auditing organizations required.
• Knowledge of pharmaceutical manufacturing business processes and how IT and automation integrate with them required.
• Excellent troubleshooting skills; ability to identify root cause of a problem and assist in determining appropriate IT or technical solutions required.
• Demonstrated skills in identifying and leading medium to large scale IT validation projects required.
• Possesses and applies a broad range of expertise of principles, methods, practices, standards, procedures and compliance requirements of a particular business function in designing and developing complex IT solutions required.
• Provides solutions which are aligned with site strategies and comply with the company’s architectural and operating standards and requirements required.
• Experience with developing and maintaining IT‑focused policies, procedures and other documents required.
• Experience with HP Application Lifecycle Management software a plus.
• Project management and capital project experience strongly preferred.

• 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 and 6 weeks paid family medical leave
• Free access to Novo Nordisk‑marketed pharmaceutical products
• Tuition Assistance
• Life and Disability Insurance
• Employee Referral Awards

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

Nuevo 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.