United States flag

Senior Manager, R&D Information Systems

United States - California - Foster CityQualityRegular
apply

Job Description

This is an individual contributor position at our Foster City, CA campus.

Overview:

The Quality Information Systems team within PDM Quality is responsible for Business Systems Ownership and Business Administration support of all of Gilead’s enterprise-wide Quality Management Systems. These include Veeva Vault QMS and QualityDocs and the ComplianceWire Learning Management System for GxP Training.

Vault QMS was recently implemented over the course of a three-year program and includes many of Veeva’s modules for managing Quality Events (Deviation, CAPA, Change Control, Lab Investigation, Complaints, Escalations, etc.), Quality Audit and Inspections, Supplier Qualification and Quality Risks. Additional implementation work is planned for 2024 & 2025 to produce at least 2-3 new modules and a major redesign of Quality Risk Management (QRM).

The global, cross-functional user community of Vault QMS has extensive reporting requirements, both ad hoc and formal, validated and non-validated, and must perform regular metrics reporting and quality management review. In addition, the users of the other Quality Systems require help with reporting and search capability within the individual applications, as well as being able to merge and leverage the data available from these applications in the Data Lake by using Gilead’s preferred analytics tools.

The Veeva Vault applications consume master data from various other source systems, including products and product families, materials, planned and manufactured batches/lots, suppliers/vendors, assets (computer systems, instruments, equipment), clinical trials, etc. This data is leveraged for associations to QMS records like Deviations, metadata on documents, and for integration with regulatory systems and SAP ERP, so it is important that it is curated, consistent and of the highest quality and accuracy.

Responsibilities:

  • As part of the Quality Information Systems team, create and lead a Reporting Center of Excellence to build, test, deploy and maintain Vault and ComplianceWire reports and dashboards.

  • Establish a network of Vault reporting Subject Matter Experts (SMEs) representing and supporting various sites and business functions.

  • Design and facilitate training sessions, workshops, and ad hoc sessions on both reporting and search, teaching tools, skills and techniques to empower the user community for self-service, to enhance the overall efficiency of reporting processes and ability to find information.

  • Create user reference documentation, communications and informational materials, and in-application help tips for the use of search and reporting features.

  • Work with the IT SQA and Validation teams to validate reports that are intended for GxP usage.

  • Perform both ad-hoc and project-driven data structuring and re-structuring activities, addressing the impact of data changes to existing reports and metrics.

  • Ensure master data elements are harmonized and well-integrated within the Vault ecosystem.

  • Design, execute, and optimize operational data check pipelines using a variety of tools (Python, SQL, Excel, etc.) to ensure alignment and consistency of Vault QMS data with source and boundary systems and across modules.

  • Work in close collaboration with the Business System Owners and business leads for the Quality Systems to understand the unmet user needs around the management and consumption of the data and opportunities to optimize our capabilities.

  • Develop working relationships with owners/managers of other boundary systems to Vault and ComplianceWire to ensure data integrations are developed and maintained appropriately and design solutions for reporting across multiple systems.

  • Apply business analysis skills to gathering and documenting requirements from business leads, the user community, and leadership stakeholders, not just for the reporting of quality data, but for the collection and use of the data through application workflows.

Knowledge and Skills:

  • Understanding of database design, data architecture and database reporting skills

  • Specific experience with Data Analytics tools, such as Tableau, ThoughtSpot, etc. is a plus

  • Specific experience with Veeva Vault products and reporting is a plus

  • GxP computer systems and validation experience

  • Knowledge of Quality Systems concepts

  • Strong verbal communication, technical writing, and interpersonal skills

  • Ability to create training materials

  • Meeting facilitation, conducting training sessions

Minimum Qualifications:

  • Bachelor's degree in computer science, engineering or life sciences and 8+ years of relevant experience in an IT or Quality-related field OR

  • Master's degree in computer science, engineering or life sciences and 6+ years of relevant experience.