Director, IT Business Partner Biopharma GXP

The Company:
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.

The Role:

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.

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 buildtesting implementation and post-implementation support ofGxP applications and related business processes.
• Develop enterprise architecture

Competencies:

• 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

Qualifications:

• Bachelors 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)

Additional Information:

Nuvalent is committed to fair and equitable compensation practices aiming to provide employees with competitive total rewards packages.

The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting but the final salary determination may be within or outside this range based on various factors including but not limited to experience skills education and market factors. The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career financial health and well-being journey including medical dental and vision insurance 401(k) retirement savings plan generous paid time off (including a summer and winter company shutdown) and much more.

Nuvalentprovides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion race creed color sex sexual orientation alienage or citizenship status national origin age marital status pregnancy disability veteran or military status predisposing genetic characteristics or any other characteristic protected by applicable federal state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants often asking for sensitive personal and financial information and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from @ email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone video conferencing and/or in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent please contact Nuvalent at . Thank you.