IT Compliance Analyst - SDF

About the role

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)
• Manage change requests & system validation for IT
• Serve as IT lead for audits
• Cover coordination 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

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