IT Validation & Compliance Lead — CSV Expert

BioSpace; West Lebanon (NH); On-site; USD 120,000 - 170,000; Full time

Job summary

Novo Nordisk is seeking a Lead IT Validation & Compliance professional for their West Lebanon, NH site to ensure CSV governance, regulatory compliance, and delivery of validated IT solutions across manufacturing and labs.

The role emphasizes cross-functional collaboration, project leadership, and driving continuous improvement within the CSV program, aligning with Novo Nordisk standards and regulatory requirements.

Qualifications

• Bachelor’s degree in IT or related field with 7+ years IT compliance exp.
• Master’s degree preferred with 5+ years IT compliance exp.
• Minimum 5 years validating and testing IT solutions.

Responsibilities

• Validate IT infrastructure, systems and computerized equipment supporting labs and manufacturing.
• Ensure IT solutions comply with 21 CFR Part 11, EU Annex 11 and GAMP.
• Develop and review validation deliverables including URS, IQ/OQ/PQ protocols.
• Lead CSV governance and drive process improvements.
• Support audits and inspections as CSV SME.

Skills

English communication

Leadership

Problem solving

Education

Bachelor's degree in Information Technology or related field

Master’s degree in Information Technology or related field

Tools

HP ALM

MS Office

Job description

Novo Nordisk is seeking a Lead IT Validation & Compliance professional for their West Lebanon, NH site to ensure CSV governance, regulatory compliance, and delivery of validated IT solutions across manufacturing and labs.

The role emphasizes cross-functional collaboration, project leadership, and driving continuous improvement within the CSV program, aligning with Novo Nordisk standards and regulatory requirements.