Director, GxP Content and Vault Platform
Director, GxP Content and Vault Platform
United States - North Carolina - Raleigh
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
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.
The Gilead Business Services center in Raleigh's Research Triangle region will be home to some of the company's critical shared service teams in North America, including Information Technology, Global Financial Solutions, HR Operations and Procurement Services Desk. These functions provide the necessary support to ensure Gilead's business runs effectively and efficiently. The center will also be a catalyst for standardization of processes, digital transformation and technology optimization.
The Director GxP Content Service and Vault Platform will lead and manage the growing Veeva Vault platform and Enterprise GxP Content supporting various initiatives rely on the platform releases and services. This involves communication with business stakeholders, both operational and development teams, and IT leadership. This role requires a combination of both technical and leadership skills, working with platforms such as Veeva Vault (GVault), FileTrail and Java based DevOps pipeline.
The role will provide guidance and oversight to technical analysts as well as related delivery teams. This role will serve as subject matter expert as representation for platform interests and assisting in development of strategic direction. This role will contribute to the development of detailed release plans including Veeva's feature set and Gilead's backlog of QualityDocs, Partner Collaboration and Records Management. Ensures identifying needs to support delivery efforts, maintains high quality and deliver platform operational service level.
Essential Duties and Job Functions
This role will be accountable for, but not limited to, the following key responsibilities:
- Lead and develop roadmaps for future development of GVault and Enterprise Records Management platforms, that support and aligned with business needs
- Provide technical and architectural guidance to projects, teams and service providers, ensuring that initiatives are effectively leveraging the platform standards
- Leads the development, publication and maintenance of the Vault platform architecture, as well as the roadmap for its future development, that matches and supports business needs.
- Serve as platform leader and primary point of contact for GVault and Records Management service portfolio that covers QualityDocs, GxP Content Services and Records Management
- Extend and maintain Vault platform governance structure and release cadence in partnership with business stakeholders and compliance goal.
- Facilitate ongoing change management and communication activities across Gilead's offices, targeted to both the broader IT organization and business stakeholders for both strategic initiatives and technology standards and platforms
- Accountable for driving technical solutions in alignment with actionable roadmaps and implementation plan
- Lead and collaborate effectively with a geographically distributed team including service providers
- In collaboration with enterprise architects and other Vault owners (eTMF, CDMS etc.), create and maintain Gilead's vault technology footprint, including utilization of third-party solutions, domain management, consistent integration pattern and cloud release strategy.
- Develop and maintain standards and policies related to the environment. Document solutions and operating procedures and train personnel on executing in accordance with the procedures.
- Implement GxP Validation protocols and create solution design, system configuration, etc. deliverables in collaboration with managed service partners.
- Drive release management activities such as creating maintenance calendars and coordinating and prioritizing defect resolution items
Associates' Degree and Fourteen Year's Experience OR Bachelor's Degree and Twelve Years' Experience OR Masters' Degree and Ten Years' Experience OR PhD and Eight Years' Experience
- Hands-on Veeva Vault platform and operations management experience
- Experience participating in and management of various cloud-based software releases, systems integration, and agile based software development projects
- Experience managing a technical team
- Industry in Pharmaceutical/Life Science industries, strongly desired
- Hands-on experience and working knowledge across content management, collaboration and search services
- Excellent understanding of mobile and API concepts and technology
- Strong DevOps pipeline with automation experience for Vault platform
- Extensive Experience in leading in Computer System Validation and GxP compliance
- Excellent written and verbal communication skills are required
- Ability to work independently and manage multiple projects and priorities
- Self-motivated, customer and delivery focused
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 email@example.com 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.
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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