Director, IT Business Partner - Biopharma GXP

Nuvalent, Inc. • Cambridge, MA

3d

About The Position

With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
Reporting to the Vice President, Information Technology, the Director, IT Business Partner, GXP will serve as a strategic technology leader responsible for aligning IT capabilities with business objectives across all GXP-regulated departments (GMP, GLP, GCP) as the organization prepares for commercial launch. This role requires deep expertise in pharmaceutical IT systems, regulatory compliance, and the ability to translate complex business requirements into scalable technology solutions that support quality, compliance, and operational excellence.

Requirements

• Deep understanding of GXP regulations and their application to IT systems
• Strong knowledge of pharmaceutical manufacturing, quality, and clinical operations
• Experience with GAMP 5, industry standards, and cloud technologies in regulated environments
• Exceptional stakeholder management and communication skills across all organizational levels
• Strategic thinker with strong business acumen and ability to deliver complex projects on time and budget
• Experience in leveraging Enterprise Architecture to deliver business value
• 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)

Responsibilities

• 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
• Lead project lifecycle activities such as planning, requirement gathering, design, build, testing, implementation and post-implementation support of GxP applications and related business processes.
• Develop enterprise architecture

What This Job Offers

• Job Type: Full-time
• Career Level: Director