IT Compliance Lead — Pharma Quality & Data Integrity

BioSpace; Clayton (NC); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Competitive pay + annual bonus

14 paid holidays

Health insurance

401K with match

Parental & family leave

Product samples

Tuition assistance

Life & disability insurance

Referral bonus

Job summary

Novo Nordisk in Clayton, NC is seeking an IT Compliance Specialist to lead validation, QA, and regulatory adherence across manufacturing IT systems. You will collaborate with cross-functional teams, support audits, and drive process improvement to ensure data integrity, product quality, and patient safety while aligning with global regulatory standards.

This role requires strong communication, risk assessment skills, and the ability to manage multiple projects to deliver compliant IT solutions

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 planning, organizing, decision making and dealing 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

Skills

IT compliance

Audits & inspections

Risk assessments

Documentation

Project coordination

Communication

Education

Bachelor's degree in IT/Engineering/Science

Master's degree (preferred)

Tools

MS Office

GxP knowledge

Job description

Novo Nordisk in Clayton, NC is seeking an IT Compliance Specialist to lead validation, QA, and regulatory adherence across manufacturing IT systems. You will collaborate with cross-functional teams, support audits, and drive process improvement to ensure data integrity, product quality, and patient safety while aligning with global regulatory standards.

This role requires strong communication, risk assessment skills, and the ability to manage multiple projects to deliver compliant IT solutions