Director, IT Business Partner - Biopharma GXP
Nuvalent, Inc.
10 hours ago
Remote friendly (Cambridge, MA)
United States
$215,000 - $235,000 USD yearly
IT
Responsibilities:
- Partner with GXP business leaders to understand strategic objectives and translate them into comprehensive IT roadmaps supporting launch readiness and sustainable operations
- 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 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 a team focused on GXP systems; manage vendor relationships
- Partner with Quality and Regulatory Affairs to support inspections and maintain compliance
- Lead project lifecycle activities (planning, requirements gathering, design, build, testing, implementation, and post-implementation support) for GxP applications and related business processes
- Develop enterprise architecture
Competencies:
- Deep understanding of GXP regulations as applied 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
- Strategic thinker with business acumen; delivers complex projects on time and within budget
- Experience leveraging Enterprise Architecture to deliver business value
Qualifications:
- Bachelor’s degree in Computer Science, Information Technology, Engineering, Life Sciences, or related field (required)
- 10+ years of progressive IT experience in pharmaceutical/biotechnology/regulated healthcare manufacturing
- 5+ years in a leadership role managing IT business partnerships, systems implementations, or GXP IT operations
- Demonstrated experience supporting commercial launch and/or significant operational scale-up
- Proven track record implementing/managing multiple GXP-regulated systems (especially Veeva)
- Hands-on CSV and regulatory compliance (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); generous paid time off (including a summer and winter company shutdown)
Application instructions:
- Submit a completed job application and complete a thorough interview process including 1:1 and/or group interviews via phone, video conferencing, and/or in-person.
- Partner with GXP business leaders to understand strategic objectives and translate them into comprehensive IT roadmaps supporting launch readiness and sustainable operations
- 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 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 a team focused on GXP systems; manage vendor relationships
- Partner with Quality and Regulatory Affairs to support inspections and maintain compliance
- Lead project lifecycle activities (planning, requirements gathering, design, build, testing, implementation, and post-implementation support) for GxP applications and related business processes
- Develop enterprise architecture
Competencies:
- Deep understanding of GXP regulations as applied 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
- Strategic thinker with business acumen; delivers complex projects on time and within budget
- Experience leveraging Enterprise Architecture to deliver business value
Qualifications:
- Bachelor’s degree in Computer Science, Information Technology, Engineering, Life Sciences, or related field (required)
- 10+ years of progressive IT experience in pharmaceutical/biotechnology/regulated healthcare manufacturing
- 5+ years in a leadership role managing IT business partnerships, systems implementations, or GXP IT operations
- Demonstrated experience supporting commercial launch and/or significant operational scale-up
- Proven track record implementing/managing multiple GXP-regulated systems (especially Veeva)
- Hands-on CSV and regulatory compliance (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); generous paid time off (including a summer and winter company shutdown)
Application instructions:
- Submit a completed job application and complete a thorough interview process including 1:1 and/or group interviews via phone, video conferencing, and/or in-person.