IT Validation & Compliance Lead (Onsite)
Novo Nordisk
August 21, 2026
On-site
West Lebanon, NH
IT
The purpose of Lead IT Validation & Compliance is to provide subject matter expertise in Computer Systems Validation (CSV), process improvement, and IT compliance service delivery management across the site.
Responsibilities:
- Lead and support IT solutions validation for IT infrastructure, IT systems, and computerized equipment supporting laboratories, manufacturing, and business areas (e.g., facilities, warehousing).
- Ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP requirements.
- Facilitate/review/approve (and develop as needed) validation deliverables: URS, DQ, FMEA, risk assessments, FAT/SAT, IQ/OQ/PQ protocols, and operating/maintenance instructions.
- Conduct risk assessments and impact analyses; develop mitigation strategies.
- Perform Quality Systems activities: document management, change control, deviations, and CAPA.
- Write/revise CSV procedures; collaborate with engineering on validation, requalification, and maintenance programs.
- Manage handover of projects to service operations; maintain documentation and release to use; support audits/inspections as CSV SME.
- Provide leadership, coach/mentor personnel, communicate with stakeholders, and deliver training for CSV/process improvement initiatives.
Qualifications:
- Bachelor’s in IT or related field + 7 years IT compliance experience (pharma API/finished production manufacturing preferred), required.
- Master’s preferred + 5 years IT compliance experience, required.
- 5+ years validation/testing of IT solutions, required.
- Experience with electronic application lifecycle software (requirements to testing/deployment), preferably HP ALM, required.
- SME experience in audits/inspections; experience with GxP, change management, deviation handling; incident/problem/change management; excellent English writing/communication; strong customer service and collaboration.
Preferred:
- COBIT certification; Lean Six Sigma Green/Black Belt; COBIT/Lean Six Sigma experience.
Required Skills:
- Strong problem solving, planning/organization, decision-making, complexity management; MS Office (expert).
Responsibilities:
- Lead and support IT solutions validation for IT infrastructure, IT systems, and computerized equipment supporting laboratories, manufacturing, and business areas (e.g., facilities, warehousing).
- Ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP requirements.
- Facilitate/review/approve (and develop as needed) validation deliverables: URS, DQ, FMEA, risk assessments, FAT/SAT, IQ/OQ/PQ protocols, and operating/maintenance instructions.
- Conduct risk assessments and impact analyses; develop mitigation strategies.
- Perform Quality Systems activities: document management, change control, deviations, and CAPA.
- Write/revise CSV procedures; collaborate with engineering on validation, requalification, and maintenance programs.
- Manage handover of projects to service operations; maintain documentation and release to use; support audits/inspections as CSV SME.
- Provide leadership, coach/mentor personnel, communicate with stakeholders, and deliver training for CSV/process improvement initiatives.
Qualifications:
- Bachelor’s in IT or related field + 7 years IT compliance experience (pharma API/finished production manufacturing preferred), required.
- Master’s preferred + 5 years IT compliance experience, required.
- 5+ years validation/testing of IT solutions, required.
- Experience with electronic application lifecycle software (requirements to testing/deployment), preferably HP ALM, required.
- SME experience in audits/inspections; experience with GxP, change management, deviation handling; incident/problem/change management; excellent English writing/communication; strong customer service and collaboration.
Preferred:
- COBIT certification; Lean Six Sigma Green/Black Belt; COBIT/Lean Six Sigma experience.
Required Skills:
- Strong problem solving, planning/organization, decision-making, complexity management; MS Office (expert).