Senior GxP IT Validation & Compliance Lead

BioSpace; West Lebanon (NH); On-site; USD 120,000 - 160,000; Full time

Job summary

Novo Nordisk in West Lebanon, NH, is seeking a Lead IT Validation & Compliance expert to ensure regulatory-compliant CSV and service delivery across the site.

You will guide IT validation activities, mentor teams, and partner with Engineering and QA to maintain governance, risk assessment, and continuous improvement.

This onsite role emphasizes compliance, quality, and patient safety as you drive efficient validation programs and support audits.

Qualifications

• Bachelor's degree in Information Technology or related field with 7+ years IT compliance experience.
• Master’s degree in Information Technology preferred with 5+ years in IT compliance.
• Minimum of five years in Validation & Testing of IT solutions.
• Experience with GxP, change management and deviation handling.
• Excellent writing and communication skills in English.

Responsibilities

• Lead IT CSV validation activities across IT infrastructure, systems and computerized equipment.
• Ensure IT solutions compliance with 21 CFR Part 11, EU Annex 11, and GAMP requirements.
• Develop validation deliverables (URS, IQ/OQ/PQ, FAT/SAT, protocols).
• Conduct risk assessments and mitigation planning for compliance issues.
• Collaborate with project teams to ensure proper documentation and release to use.
• Provide guidance and leadership in CSV and process improvement.
• Support audits and inspections with necessary documentation.
• Maintain governance, change control, deviations, and CAPA processes.

Skills

Leadership

Written and spoken English

Problem solving

Planning and organizing

Team collaboration

Customer service orientation

MS Office expert

Regulatory knowledge

Education

Bachelor's degree in Information Technology or related field

Master’s degree in Information Technology (preferred)

COBIT Certification

Tools

HP ALM

Job description

Novo Nordisk in West Lebanon, NH, is seeking a Lead IT Validation & Compliance expert to ensure regulatory-compliant CSV and service delivery across the site.

You will guide IT validation activities, mentor teams, and partner with Engineering and QA to maintain governance, risk assessment, and continuous improvement.

This onsite role emphasizes compliance, quality, and patient safety as you drive efficient validation programs and support audits.