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Nuvalent

Nuvalent is a biotechnology research company developing precisely targeted therapies for patients with cancer. To do so, Nuvalent employs professionals across a

Director, IT Business Partner – Biopharma GXP

Location

Massachusetts

Posted

81 days ago

Salary

$215K - $235K / year

Seniority

Lead

Bachelor Degree10 yrs expEnglishPMP

Job Description

Director, IT Business Partner – Biopharma GXP

Nuvalent

• 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

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)

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