IT Validation & Compliance Lead (Onsite)
Novo Nordisk
8 hours ago
On-site
West Lebanon, NH
IT
The purpose of Lead IT Validation & Compliance is to provide subject matter expertise in Computer Systems Validation, process improvement, and IT compliance service delivery management across the site. Ensure IT solutions are implemented and released in compliance with relevant regulations and standards, enabling seamless transition and handover of projects to service operations.
Responsibilities:
- Lead/participate in IT solutions validation (IT infrastructure, IT systems, computerized equipment supporting labs, manufacturing, and business areas such as facilities and warehousing)
- Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP, and related standards
- Facilitate/review/approve and develop validation deliverables (URS, DQ, FMEA, risk assessments, FAT/SAT, IQ/OQ/PQ protocols, operating/maintenance instructions)
- Conduct risk assessments and impact analyses; develop mitigation strategies
- Support project teams; continuously improve documentation/processes; identify CSV efficiencies and stay current on regulatory changes
- Perform Quality System activities (document management, change control, deviations, CAPA)
- Write/revise CSV procedures; collaborate with Engineering on validation/requalification/maintenance program
- CSV service delivery management: handover to service operations, maintain compliant documentation, support audits/inspections, ensure solutions are documented and released
- Provide leadership, coaching/mentorship, stakeholder communication, problem-solving (including deviations) and controlled change implementation; develop/deliver training
Qualifications:
- Bachelor’s in IT (or related), 7+ years IT compliance (pharma API and/or finished production manufacturing) (required)
- Master’s (preferred) with 5+ years IT compliance (required)
- 5+ years validation/testing of IT solutions (required)
- COBIT (preferred); Lean Six Sigma Green/Black Belt (preferred)
- Electronic application lifecycle experience (requirements to testing/deployment), preferably HP ALM (required)
- SME in audits/inspections (required)
- GxP, change management, deviation handling; Incident/Problem/Change Management in IT (required)
- Excellent English writing/communication; customer service; collaboration; problem-solving and conflict management; planning/organizing and decision-making; MS Office expert (required)
Responsibilities:
- Lead/participate in IT solutions validation (IT infrastructure, IT systems, computerized equipment supporting labs, manufacturing, and business areas such as facilities and warehousing)
- Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP, and related standards
- Facilitate/review/approve and develop validation deliverables (URS, DQ, FMEA, risk assessments, FAT/SAT, IQ/OQ/PQ protocols, operating/maintenance instructions)
- Conduct risk assessments and impact analyses; develop mitigation strategies
- Support project teams; continuously improve documentation/processes; identify CSV efficiencies and stay current on regulatory changes
- Perform Quality System activities (document management, change control, deviations, CAPA)
- Write/revise CSV procedures; collaborate with Engineering on validation/requalification/maintenance program
- CSV service delivery management: handover to service operations, maintain compliant documentation, support audits/inspections, ensure solutions are documented and released
- Provide leadership, coaching/mentorship, stakeholder communication, problem-solving (including deviations) and controlled change implementation; develop/deliver training
Qualifications:
- Bachelor’s in IT (or related), 7+ years IT compliance (pharma API and/or finished production manufacturing) (required)
- Master’s (preferred) with 5+ years IT compliance (required)
- 5+ years validation/testing of IT solutions (required)
- COBIT (preferred); Lean Six Sigma Green/Black Belt (preferred)
- Electronic application lifecycle experience (requirements to testing/deployment), preferably HP ALM (required)
- SME in audits/inspections (required)
- GxP, change management, deviation handling; Incident/Problem/Change Management in IT (required)
- Excellent English writing/communication; customer service; collaboration; problem-solving and conflict management; planning/organizing and decision-making; MS Office expert (required)