Associate Director, R&D Information Systems, Quality Information Systems Veeva Vault QMS Lead
Associate Director, R&D Information Systems, Quality Information Systems Veeva Vault QMS Lead
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
Associate Director, R&D Information Systems
Quality Information Systems - Veeva Vault QMS Lead
Key member of the Quality Information Systems team partnering with IT, PDM (Product Development and Manufacturing) and Development organizations in support of global enterprise systems. This position acts as the Implementation Program Lead and Business Process Owner (BPO) for the Veeva Vault QMS system. This is a 3-year implementation program of a new system, replacing Sparta TrackWise and Oracle Agile, to manage deviation, CAPA, change control, lab and external event investigations, product complaints, audits, quality risk management, and more. As the new system is implemented and rolled out in phases, this role becomes the BPO overseeing the business use, procedures and training, enhancements, maintenance and change management for the operational system. This position sits within the PDM organization but supports business processes and stakeholders across all of Gilead, Kite and the affiliates, 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 Quality Management System is being built on the Veeva Vault platform which is already used as Gilead's controlled document management system. Veeva Vault is a cloud-based SaaS system, and this role involves collaboration and partnership with the vendor and Gilead IT to plan configuration enhancements and decide how to best leverage the Vault products and features 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, including 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.
- Provide business leadership and coordination of requirements, testing and migration activities during the implementation of this complex QMS system involving multiple quality event management processes.
- Act as main point-of-contact to the vendor to ensure the delivered system meets business needs, and ensure business readiness with procedures, training and communications.
- Strive for consistency in design and user experience across the different event types and workflows, and champion the use of master data, integration with other Gilead systems, and strategic use of artificial intelligence to provide transformative capabilities to the organization.
- Lead cross-functional multi-site Business Leads meetings, capturing issues, proposing process improvements and system enhancements, and tracking action items.
- Coordinate the prioritization of business requests, and liaise with IT for technical feasibility assessment, implementation planning, testing and execution.
- Actively engage in solution design by having a deep understanding of both the business needs and the system configuration capabilities.
- Accountable for managing a team of resources to author and maintain user requirements, author and maintain business procedures and user documentation, review and execute PQ validation testing, and develop and maintain training materials.
- Participate in Vault Quality Governance Committee meetings with leaders in each of the business stakeholder organizations to provide oversight of the entire program and Vault Quality platform and alignment with strategic initiatives.
- Define and utilize metrics to measure compliance and process effectiveness and identify opportunities for improvement.
- Partner with IT and Quality to maintain the validated state of the systems, monitor user compliance with training qualifications and procedural requirements, ensure data integrity across integrated systems and manage inspection readiness.
Knowledge & Skills
- Requirements gathering, business analysis and business process mapping.
- Ability to coordinate efforts and achieve alignment across a global organization and across different business functions.
- 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 harmonization, 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.
Required Education & Experience
- A Bachelor's Degree in a Science related field, Computer Science, or Information Management and a minimum of ten (10) years of relevant experience, OR a Master's Degree in a Science related field, Computer Science, or Information Management and a minimum of eight (8) years of experience.
- Pharma/Biotech industry experience.
- Demonstrated program and project management skills, ability to deliver within a budget.
- Experience managing a team of other employees or contractors
- 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.
- Strong people skills, primarily communication, teamwork and relationship-building.
- Prior experience with Quality Management Systems such as TrackWise and/or Veeva Vault.
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.yello.co/external/form/24a8oU4jF5UL3CKq7lO_Cg
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.
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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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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.
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