IT Validation & Compliance Lead (Onsite)

Scorpion Therapeutics; New Hampshire; On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a Lead IT Validation & Compliance professional in New Hampshire to lead IT solutions validation across laboratories, manufacturing, and business areas. You will ensure 21 CFR Part 11, EU Annex 11, and GAMP compliance while developing and reviewing validation deliverables and risk mitigations.

You will manage QA activities, document control, deviations, CAPA, and collaborate with engineering on maintenance.

Qualifications

• Bachelor’s in IT or related field; 7+ years IT compliance experience.
• Master’s degree preferred.
• 5+ years validation/testing of IT solutions.
• Experience with electronic lifecycle software (HP ALM) required.
• GxP, audits/inspections, change management experience; strong English writing.

Responsibilities

• Lead and support IT solutions validation for IT infrastructure, IT systems, and computerized equipment across labs, manufacturing, and business areas.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP requirements.
• Develop and review validation deliverables: URS, DQ, FAT/SAT, IQ/OQ/PQ, and maintenance instructions.
• Conduct risk assessments and mitigation strategies.
• Perform Quality Systems activities: document management, change control, deviations, and CAPA.
• Write/revise CSV procedures; collaborate on validation, requalification, and maintenance programs.
• Handover projects to service operations; support audits/inspections as CSV SME.
• Provide leadership, coaching, and CSV/process improvement training.

Skills

IT compliance

Validation

Documentation

Stakeholder comms

MS Office

GxP

Education

Bachelor's degree in IT or related field

Master's degree (preferred)

Tools

HP ALM

Job description

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).