Aldous Gorospe

About Aldous Gorospe

As an IT Business Partner, acts as a strategic bridge between IT and business units, translating needs into tech solutions, aligning IT strategy with company goals, managing projects, optimizing technology spending, and driving digital transformation by improving processes and bridging communication gaps between technical teams and business leadersAs an IT R&D System Owner, is ultimately responsible for an entire IT SDLC from procurement and development to operation, maintenance, and eventual retirement, ensuring it meets business needs, security requirements, and compliance, essentially championing the system and overseeing its resources, budget, security, and lifecycle roadmapThe following lists the R&D systems that is I am responsible for:• Regulatory (Vault Submissions, Vault Submission Archive)• Publishing (DocuBridge, Extedo)• Clinical Operations (Vault eTMF)• Clinical Data Management (Vault EDC)• Commercial (Vault MedComms, Vault PromoMats)• Quality (Vault QualityDocs, Vault QMS, Vault Training, Veeva LearnGxP)• Statistical Data Management System (Instem)• Pharmacovigilance (ArisG)

Experience

1. System Owner

   Roivant

   Feb 2022 — Present

   In addition to GxP System Owner for IT R&D Systems, responsibilities were expanded to include the IT Business Partner role:Leads the roadmap, selection, implementation, and operational support of Roivant’s IT R&D portfolio of GxP platforms and applications. This role is responsible for architecting and executing a forward-looking roadmap that integrates automation, and analytics to enhance R&D user experience, operational efficiency, and data-driven decision-making across the R&D functions. The IT Business Partner collaborates with senior leaders and other key stakeholders across several areas of the business to identify, prioritize and deliver technology solutions in support of their goals and objectives.· Partner with business stakeholders across R&A to manage and prioritize the technology portfolio and continually build the future roadmap of R&D applications· Oversee a diverse portfolio of projects, programs, and system enhancements, ensuring timely, high-quality, and cost-effective delivery · Manage and strengthen relationships with Roivant’s strategic software vendors and external service partners. · Ensure all R&D platforms and systems comply with data privacy, security, and applicable regulatory requirements. · Lead and develop a small team of IT professionals and contractors, fostering growth, collaboration, and accountability.

Education

• De La Salle University

  Industrial and Management Engineering

Skills

• Consulting
• Computer System Validation
• U.s. Title 21 Cfr Part 11 Regulation
• Management
• Pharmaceutical Industry
• Sop
• Business Analysis
• Vendor Management
• V&V
• Integration
• Testing
• Requirements Analysis
• Validation
• Quality Assurance
• 21 Cfr Part 11
• Gxp
• Quality Auditing
• Project Planning
• Gamp
• Software Documentation