Senior IT Compliance & Validation Analyst

NCBiotech; Clayton (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K matching

Paid time off + holidays

Job summary

Novo Nordisk in Clayton, NC seeks an IT Compliance expert to provide subject matter expertise in IT compliance, process improvement, and service delivery management across the site. You will ensure IT solutions meet regulatory standards and drive governance, data integrity, and patient safety.

The role focuses on guiding validation, risk assessment, and handover to operations, with opportunities to influence lifecycle management and cross-functional collaboration in a leading pharmaceutical

Qualifications

• Bachelor’s Degree in IT, Engineering, Science, or relevant field of study from an accredited university required
• Master’s degree in IT, Engineering, Science, or relevant field of study from an accredited university preferred
• Minimum of seven (7) years of experience in IT compliance required, preferably within the pharmaceutical industry
• Minimum of five (5) years of experience on Validation and Testing of IT Solutions required, preferably within the pharmaceutical industry
• Certified Information Systems Auditor (CISA) is preferred
• Lean Six Sigma Green Belt or Black Belt is preferred
• Experience as SME participating in Audits and Inspections preferred
• Experience on GxP, change management and deviation handling preferred
• Experience with Incident, Problem, and Change Management in IT preferred
• Excellent writing and communication skills, in English required
• Excellent customer service skills and ability to collaborate effectively in a team environment required
• Excellent problem solving, negotiation, conflict management, and interpersonal skills required
• Excellent planning, organizing, decision making and deal with complexity and ambiguity required
• Strong computer skills and MS Office Expert required

Responsibilities

• Develop and maintain validation and qualification documentation
• Conduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategies
• Provide guidance and support to project teams on validation and qualification requirements
• Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards
• Facilitate the seamless transition and handover of projects to service operations with key stakeholders
• Maintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirements
• Participate as an IT SME in audits and inspections and provide needed documentation to demonstrate validated state and proper management of IT solutions throughout the life cycle
• Collaborate with cross-functional teams to ensure that all IT solutions meet business needs, are delivered on time & within budget, are properly documented, and managed throughout their life cycle
• Ensure that all IT solutions, documentation, and processes are following regulatory requirements and Novo Nordisk standards
• Provide leadership and expertise in IT compliance, process improvement, and project coordination
• Coach and mentor personnel, and provide guidance as needed
• Participate in process group meetings and contribute to process group activities
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Skills

Communication skills

English proficiency

Team collaboration

Problem solving

Decision making

Interpersonal skills

Education

Bachelor's degree in IT/Engineering/Science

Master's degree in IT/Engineering/Science

Tools

MS Office

Job description

Novo Nordisk in Clayton, NC seeks an IT Compliance expert to provide subject matter expertise in IT compliance, process improvement, and service delivery management across the site. You will ensure IT solutions meet regulatory standards and drive governance, data integrity, and patient safety.

The role focuses on guiding validation, risk assessment, and handover to operations, with opportunities to influence lifecycle management and cross-functional collaboration in a leading pharmaceutical