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Validation and Assurance Strategy Lead at Gilead Sciences - ApplyBlast

Validation and Assurance Strategy Lead

Gilead Sciences

21 days ago

3.5 on Glassdoor

Frederick, Maryland, United States

Onsite

Full Time

Senior

0 applicants

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About this role

This role focuses on developing and executing risk-based validation and assurance strategies for GxP computerized systems within a regulated life-sciences environment. The position involves leading lifecycle execution, maintaining validated states, ensuring data integrity, and overseeing supplier and technology assurance. The role requires strong leadership capabilities to guide cross-functional teams and drive inspection readiness while adhering to quality standards and regulatory guidance.

Responsibilities

Develop risk-based validation and assurance strategies for GxP computerized systems
Lead lifecycle execution including requirements, testing, and release decisions
Maintain validated state through change control, periodic reviews, and supplier oversight

Skills

Qualifications

Bachelor's degree in life sciences, engineering, computer science, information systems, Quality, or a related discipline

About Gilead Sciences

gilead.com

Headquarters

Foster City, California, United States

Company Size

10001+ employees

Founded

1987

View Profile

Gilead Sciences is a biopharmaceutical company dedicated to transforming patient care by advancing therapeutics in areas like HIV, liver disease, cancer, and inflammation. With a strong commitment to innovation, Gilead leads in the research and development of new medicines, aiming to make the world a healthier place. Their portfolio includes breakthrough therapies and ongoing advancements across multiple therapeutic areas, supported by a robust pipeline of clinical trials. Gilead is recognized for its contributions to public health and its efforts to improve access to vital medications.