IT Compliance Lead

We are looking for an IT Compliance Lead for a global pharmaceutical manufacturing organization in Richmond, VA or Raleigh, NC. This role will own CSV strategy, ensure systems meet GxP regulations, lead IT governance documentation, support audits, and partner with IT leadership on enterprise compliance initiatives.

Job Logistics

Location: Richmond, VA or Raleigh, NC

Travel: Minimal

Work model: Hybrid; onsite Tues-Thurs

Tools/Tech: Veeva, MES, LIMS, ValGenesis, TrackWise, AuditBoard, DocuSign/Adobe

DAY TO DAY RESPONSIBILITIES

• Lead global Computer Systems Validation (CSV) strategy
• Maintain IT compliance procedures, best practices, and governance
• Review and approve IT governance and risk documentation
• Partner with IT leadership on new initiatives
• Support and train compliance team members
• Oversee GxP risk reviews and regulated system implementations
• Act as IT contact for internal, financial, and ITGC audits
• Support Veeva, MES, LIMS, and electronic signature platforms

REQUIREMENTS

• Bachelor’s degree
• 7+ years in pharmaceutical IT, GxP, and manufacturing systems
• Strong working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP
• 3+ years leadership experience in CSV
• Experience with Veeva, MES, LIMS, ValGenesis, and AuditBoard
• Experience supporting inspections by regulatory authorities
• Strong communication and documentation leadership
• Experience managing audits and training teams

Plusses:

• Global compliance experience
• Broader IT lifecycle & project management background

Compensation

Compensation: $155,000 to $175,000. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.