Partner with GXP business leaders to understand strategic objectives and translate them into comprehensive IT roadmaps that support launch readiness and sustainable operations
Oversee selection, implementation, and validation of critical GXP systems
Ensure all IT systems comply with FDA 21 CFR Part 11, EU Annex 11, and data integrity requirements (ALCOA+)
Lead Computer System Validation (CSV) activities and maintain audit readiness
Drive IT readiness for commercial launch including system scalability, disaster recovery, and capacity planning
Build and lead team of IT professionals focused on GXP systems; manage vendor relationships
Partner with Quality and Regulatory Affairs to support inspections and maintain compliance
Project management experience
Develop enterprise architecture

Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or related field required
10+ years of progressive IT experience in pharmaceutical, biotechnology, or regulated healthcare manufacturing environments
5+ years in a leadership role managing IT business partnerships, systems implementations, or GXP IT operations
Demonstrated experience supporting commercial launch activities or significant operational scale-up in a pharmaceutical setting
Proven track record implementing and managing multiple GXP-regulated systems, especially Veeva systems
Hands-on experience with Computer System Validation (CSV) and regulatory compliance requirements (21 CFR Part 11, EU Annex 11, data integrity)
Experience managing IT budgets, vendor relationships, and cross-functional projects
PMP, ITIL, or relevant IT certifications
Knowledge of serialization, track-and-trace, and emerging technologies (AI/ML, analytics)

Director, IT Business Partner – Biopharma GXP

Key skills