Sr Manager, R&D Information Systems

Sr Manager, R&D Information Systems
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Sr Manager, R&D Information Systems

Specific Responsibilities and Skills for Position:

Key member of the Quality Management Systems team partnering with IT, PDM (Product Development and Manufacturing) and DevOps organizations in support of global enterprise systems. This position acts as the Business Process Owner (BPO) for the GxP document management and learning management systems, ensuring effective and productive engagement, prioritization, alignment and decision-making among the key stakeholders across all the business organizations. This position sits within the PDM organization but supports business processes and stakeholders across all of Gilead, both within and outside of PDM.

This role involves a combination of operational and project responsibilities, with a business analysis and quality focus. Gilead's document management system is built on the Veeva Vault QualityDocs platform and is used for both managing Gilead internal controlled documents and for exchanging documents with contract partners. Gilead's learning management system is based on ComplianceWire. Both are cloud-based SaaS systems and this role involves collaboration and partnership with the vendors to plan enhancements and decide how to best leverage the products to meet business needs. This role is the key business representative in various governance committees, with the goal of ensuring compliance and optimizing business efficiency. The BPO role has responsibilities formally defined in procedures, such as approval of change control, validation and procedural documentation, as well as investigating and documenting any quality events such as deviations and CAPAs associated with the system or supporting business processes.

Responsibilities:

• Lead the cross-functional multi-site Business Leads meetings for the document management and learning management systems, capturing issues, proposed process improvements and proposed system enhancements, and assigning and tracking action items
• Coordinate the prioritization of system issues and enhancement requests among the Business Leads, and liaise with IT for technical feasibility assessment, implementation planning, testing and execution.
• Author and maintain user requirements, business process documentation and controlled procedural documentation for the document management and learning management systems.
• Work with Training Administration groups across the organization to ensure training materials and qualification requirements for usage of the system are kept up to date and are effective for the trainers and the learners.
• Design and monitor business processes for efficiency and compliance.
• Understand the system configuration and integration design and recommend configuration changes to optimize the use of the systems for all stakeholder groups.
• Lead the system Governance Committee meetings with leaders in each of the business stakeholder organizations who provide oversight of the entire program and ensure proper resources are in place to deliver the prioritized system and process changes and support new initiatives.
• Define and utilize metrics to measure process effectiveness and areas of opportunity for future process improvement.
• Play a key role in projects to assess, implement and roll-out new computer systems in the Quality Systems area, such as other Veeva products in the QualitySuite, or integrations between multiple systems to improve automation and data integrity.
• 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 to maintain the validated state of the systems, ensuring data integrity across integrated systems, ensuring training curricula are current and appropriate, and managing inspection readiness

Knowledge, Experience and 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.
• Strong verbal communication skills, including ability to explain technical concepts to non-technical people, translate business needs into technical solutions, and deal with controversial topics with sensitivity and persuasion skills.
• Team leadership and ability to influence.

Requirements

• 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.
• Ability to organize work and track progress; basic project management skills.
• Ability to manage a small team of other employees or contractors and coordinate their work to meet all the responsibilities defined above and achieve the program goals
• 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.

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes 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.


For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

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PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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:
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