Sr. Manager, Development Systems - CSV (Computer Systems Validation)
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. Gilead’s 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 company’s five core values. That’s 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 #CreatingPossibleFor Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.Job DescriptionJob Description - Senior Manager, Development Systems (Computer Systems Validation)
This position will implement strategy to increase effectiveness and efficiencies in the computer systems validation and testing processes, and lead computer systems validation and testing initiatives for the Development Systems at Gilead Sciences.The specific RESPONSIBILITIES for this position will include the following:
The specific KNOWLEDGE, EXPERIENCE AND SKILLS will include the following:
- Provide leadership for Validation and Testing teams in support of the Gilead and department strategy
- Partner with IT, QA and Development Systems stakeholders to define, implement, and improve quality standards, tools, and methods
- Evaluate and define methodologies to drive testing efficiencies through test automation
- Cross train on Development Systems functionality and integration points to ensure appropriate level of testing
- Hiring, mentoring and developing members of the validation team
- Help developing and implementing a risk-based approach to validation
- Be able to analyze and solve problems, champion new processes and evaluate and learn new technologies to support testing and validation efforts
- Lead and collaborate with cross functional teams, including business partners, Gilead IT and vendors
- Be able to analyze and solve problems, champion new processes and evaluate and learn new technologies
- Serve as subject matter expert for Development Systems validation supporting CAPAs, internal and external audits and inspections as required
- Develop and track metrics to monitor application and system quality and deliverables for validation and testing
- Collaborates cross-functionally and geographically with stakeholders to ensure the validation and testing processes are aligned to the needs of Gilead, ensuring that best practices, compliance and alignment with business needs
- Knowledge, prior experience and demonstrated success leading validation efforts for medium to large system implementations
- Experience working with Waterfall, Iterative and Agile methodologies
- Experience and ability to manage staff, both FTEs and contractors
- Prior experience implementing test automation
- Proficiency with Microsoft Office Suite (Project, Visio, Excel and PowerPoint).
- Proficiency with HP ALM
- Broad technical knowledge including experience with SaaS and Cloud systems in a GxP environment
- Excellent verbal and written communication skills with ability to communicate effectively and proactively at all levels of the organization
- Strong interpersonal skills, including strong ability to influence cross-functional stakeholders in different part of organization
- Ability to work on multiple concurrent projects
- Anticipate conflicting needs and proactively resolves them
- Ability to effectively lead and collaborate with project team members, including remote participants
- Thorough knowledge of GxP compliance
- Experience driving adoption of new procedures and technologies
- Bachelor's degree with 8+ years of experience in leading and managing computer systems validation and testing
- Master's degree with 6+ years of experience in leading and managing computer systems validation and testing
- Experience and education in Life Sciences or pharma preferred
- Ability to work different time zone hours and travel as required
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.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the 'EEO is the Law'
poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY 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:
Please log onto your Internal Career Site
to apply for this job.