Associate Director IT Business Systems R&D

Responsibilities

• Support, administer, maintain IT systems supporting Quality and R&D, including Veeva Vault Quality, Clinical, RIM and Safety systems.
• Lead and oversee the migration of data and processes from legacy systems to Veeva (e.g., ZenQMS to Veeva Vault Quality) to ensure seamless transition, data integrity, and GxP compliance
• Partner with business leaders to understand their requirements and continuously improve user adoption and implement new systems, integrations, and GxP compliance initiatives
• Partner with Quality, Clinical, Regulatory, and Safety leaders to support business needs, implement roadmaps, identify, recommend solutions (e.g., Artificial Intelligence (AI)) to drive business value and accelerate innovation
• Work with Managed Service providers and internal IT teams for supporting and monitoring GxP-regulated systems to ensure high-quality service delivery
• Collaborate with CSV QA and compliance functions to validate and ensure alignment with regulatory requirements (e.g., GxP, HIPAA, GDPR)
• Establish governance, documentation, and change control procedures for GxP systems to ensure sustained compliance and operational excellence.
• Drive continuous improvement across the GxP systems landscape by assessing emerging technologies (e.g., AI) and optimizing workflows that support BridgeBio’s business strategy.

Where You’ll Work

• This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Bachelor’s degree in information technology, Computer Science, Business Administration, or related field; advanced degree preferred
• 7+ years of progressive IT experience within biotech/pharma, including at least 5 years supporting Veeva Quality systems
• Demonstrated expertise in GxP Quality processes, including document lifecycle management, training assignment and compliance tracking, deviation, CAPA, and change control workflows, and inspection readiness. Ability to partner with Quality stakeholders to design, configure, and continuously improve Veeva Vault QualityDocs,
• QMS, and Training solutions in alignment with regulatory expectations (e.g., FDA, EMA) and company SOPs
• Hands-on experience administering and supporting Veeva Vault Quality systems including RIM, Safety and eTMF is strongly preferred
• Experience applying AI/ML and generative AI solutions within GxP environments to improve Quality operations, including use cases such as intelligent document authoring, metadata extraction, quality event trend analysis, and training effectiveness insights, with a strong focus on validation, auditability, data privacy, and integration with Veeva Vault platforms.
• Skilled in leading cross-functional collaboration across Quality, Clinical, Regulatory, and DSPV teams to ensure system alignment and process harmonization
• Experienced in vendor and Managed Service Provider oversight to ensure reliable, compliant, and high-quality system performance
• Strong communication, leadership, and stakeholder management skills with the ability to translate technical concepts into business outcomes