Tech Stack

Description

You will serve as a strategic technology leader, aligning IT capabilities with business objectives across all GXP-regulated departments (GMP, GLP, GCP) to support commercial launch. This involves overseeing GXP systems, ensuring regulatory compliance, leading Computer System Validation, and building a team of IT professionals.

Requirements

• Bachelor's in Computer Science, IT, Engineering, Life Sciences, or related field
• 10+ years IT experience in pharmaceutical, biotech, or regulated healthcare manufacturing
• 5+ years leadership role managing IT business partnerships or GXP IT operations
• Experience supporting commercial launch or significant operational scale-up in pharma
• Hands-on experience with Veeva systems and CSV under 21 CFR Part 11 and EU Annex 11

Responsibilities

• Partner with GXP business leaders to translate objectives into IT roadmaps for launch readiness
• Oversee selection, implementation, and validation of critical GXP systems
• Ensure IT systems comply with FDA 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+)
• Lead Computer System Validation (CSV) activities and maintain audit readiness
• Build and lead team of IT professionals focused on GXP systems