GxP IT Validation & Compliance Lead

Biopharma Careers; West Lebanon (IN); On-site; USD 120,000 - 160,000; Full time

Job summary

Novo Nordisk West Lebanon, NH site seeks Lead IT Validation & Compliance to provide subject matter expertise in computer systems validation, process improvement, and IT compliance service delivery across the site. This onsite role supports governance and data integrity to ensure product quality and patient safety.

You will lead validation activities, collaborate with Engineering, coordinate audits, and mentor staff while adhering to 21 CFR Part 11, EU Annex 11, and GAMP.

Qualifications

• Bachelor’s degree in IT or related field with 7+ years IT compliance experience.
• Master’s degree preferred with 5+ years IT compliance experience.
• Minimum of five (5) years of experience in Validation & Testing of IT solutions, required
• COBIT Certification is preferred
• Lean Six Sigma Green Belt or Black Belt is preferred
• Experience with electronic application lifecycle software, from requirements gathering to testing and deployment, preferably HP ALM, required
• Experience as SME participating in Audits and Inspections, required
• Experience on GxP, change management and deviation handling, required
• Experience with Incident, Problem, and Change Management in IT, required
• Excellent writing and communication skills, in English, required

Responsibilities

• Lead IT Validation & Compliance initiatives across site
• Validate IT infrastructure, systems, and computerized equipment
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP
• Develop validation deliverables (URS, DQ, FMEA, Risk Assessments, FAT, SAT, IQ/OQ/PQ)
• Conduct risk assessments and mitigation planning
• Support project teams on validation requirements
• Improve CSV processes and documentation
• Coordinate with Engineering for validation/maintenance programs
• Serve as CSV SME during audits and inspections

Skills

IT compliance expertise

Validation & Testing

Audits & Inspections

Change Management

Documentation / Writing

GxP knowledge

English communication

Problem solving / negotiation

Education

Bachelor's degree in Information Technology or related field

Master’s degree in Information Technology or related field

Tools

HP ALM

Job description

Novo Nordisk West Lebanon, NH site seeks Lead IT Validation & Compliance to provide subject matter expertise in computer systems validation, process improvement, and IT compliance service delivery across the site. This onsite role supports governance and data integrity to ensure product quality and patient safety.

You will lead validation activities, collaborate with Engineering, coordinate audits, and mentor staff while adhering to 21 CFR Part 11, EU Annex 11, and GAMP.