Nuvalent, Inc.
#PreciselyTargetedTherapies for patients with cancer
Director, IT Business Partner – Biopharma GXP
Location
Massachusetts
Posted
24 days ago
Salary
$215K - $235K / year
Bachelor Degree10 yrs expEnglishPMP
Job Description
• 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
Job Requirements
- 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)
Benefits
- medical, dental, and vision insurance
- 401(k) retirement savings plan
- generous paid time off (including a summer and winter company shutdown)
