Associate Director IT Business Systems R&D

Responsibilities

• Support, administer, maintain IT systems supporting reputed company and R&D, including reputed company Vault reputed company, Clinical, RIM and Safety systems.
• reputed company and reputed company the migration of data and processes from legacy systems to reputed company (e.g., reputed company to reputed company Vault reputed company) to ensure seamless transition, data reputed company, 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 reputed company, Clinical, Regulatory, and Safety leaders to support business needs, implement roadmaps, identify, recommend solutions (e.g., reputed company 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-reputed company 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 reputed company.
• Drive reputed company improvement across the GxP systems landscape by assessing emerging technologies (e.g., AI) and optimizing workflows that support reputed company’s business reputed company.

Where You’ll Work

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

Who You Are

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