Gilead Sciences, Inc. Sr. Manager, R&D Info Systems - GXP Documentation Management and Learning Management Systems in Foster City, California

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Specific Responsibilities and Skills for Position:

Key member of the Quality Management Systems team who partners with IT, PDM (Process Development and Manufacturing) and DevOps organizations in support of enterprise systems for GxP document management and learning management, ensuring there is effective and productive engagement between the key stakeholders across business organizations and IT. This position sits within the PDM organization, but supports business processes and stakeholders across all of Gilead, both within and outside of PDM.

This position involves a combination of operational and project responsibilities, with a business analysis and quality focus.

  • Author and maintain user requirements, business process documentation and controlled procedural documentation for the document management and learning management systems, ensuring these systems meet business needs.

  • Design and monitor business processes for efficiency and compliance.

  • Perform centralized business administration of system configuration, and recommend configuration changes to optimize the use of the systems for all stakeholder groups.

  • Manage the analysis, prioritization and governance for system enhancements and change control processes.

  • Work with Business Process Management team to develop and maintain a catalog of document management and training business processes leveraging the computer systems, identifying metrics to measure process effectiveness and areas of opportunity for future process improvement.

  • Play a key role in projects to implement and roll-out new computer systems, including Veeva Vault QualityDocs, and possibly other Veeva products.

  • Lead and participate in business activities required on these projects, such as reviewing and executing PQ validation testing, authoring business procedures and user documentation, contributing to and reviewing training materials, and providing user support for new software releases.

  • Partner with IT and Quality in maintaining the validated state of the systems, ensuring data integrity across integrated systems, ensuring training curricula are current and appropriate, and managing inspection readiness.

  • Future development opportunity to take on Business Ownership of quality management computer systems and manage other operational and project resources.

Skills:

  • Requirements gathering, business analysis and business process mapping.

  • Ability to assemble information and coordinate efforts across a variety of business functions and processes.

  • Critical thinking and analysis skills to conceive and design solutions to a wide variety of business problems, where the solutions could involve technology, process improvement or consistency, documentation and/or training.

  • Skill in building effective working relationships with business partners.

  • Strong written communication skills including technical writing, quality/compliance documents and end-user communication.

  • Ability to explain technical concepts to non-technical people and translate business needs into technical solutions.

  • Team leadership and ability to influence.

  • Ability to organize work and track progress; basic project management skills

Essential Duties and Job Functions:

  • Finalize the business process catalog for the new Veeva Vault QualityDocs document management system, defining and evaluating effectiveness checks as needed for specific system configuration decisions and procedural controls.

  • Maintain list of prioritized enhancement requests, analyze and communicate the impact and benefits of proposed enhancements, and plan periodic system releases to implement enhancements.

  • Coordinate regular meetings with key stakeholders to drive for alignment and agreement, documenting decisions, actions and issues.

  • Ensure team members follow the appropriate governance processes and controlled procedures for operational and major system changes.

  • Perform risk assessment of all proposed changes, thinking through expected and unexpected impact.

  • Investigate issues and follow up on corrective actions associated with identified systems, documenting the outcome of these assessments in partnership with Quality Assurance.

Knowledge, Experience and Skills:

  • Experience in business analysis, user requirements documentation and business process mapping.

  • Experience in planning and implementing new IT systems and/or major system upgrades.

  • Training and experience in GxP computer system validation to meet regulatory requirements, including 21 CFR 11 & EU Annex 11 compliance, and change control.

  • Basic project management skills.

  • Strong people skills, primarily communication, teamwork and relationship-building.

  • Ability to learn quickly and apply creative and analytical problem-solving.

  • Pharma/Biotech industry experience preferred.

  • Prior experience working with document or content management systems, learning management systems, or other quality management systems preferred.

  • 8+ years of relevant experience and bachelor’s degree in science, computer science, or information management.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead