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Senior Manager, Quality Assurance (GMP Operations) at Gilead Sciences - ApplyBlast

Senior Manager, Quality Assurance (GMP Operations)

Gilead Sciences

4 months ago

3.5 on Glassdoor

California

Onsite

Full Time

Senior

0 applicants

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About this role

As a Senior Manager of Quality Assurance for GMP Operations at Gilead, you will provide quality leadership and oversight for the Manufacturing and Quality Control teams at the Foster City site. You will lead the oversight of external QC laboratories, ensure GMP compliance for biologics manufacturing, and drive continuous improvement through risk management and system validation. This role involves managing batch release activities, overseeing new facility designs, and ensuring regulatory alignment for patient safety.

Responsibilities

Provide Quality Assurance oversight of external QC laboratories
Design and plan new biologics manufacturing facilities
Manage batch record review and product release activities
Apply risk management principles to oversee quality assessments
Oversee design and approval of standard operating procedures

Skills

Qualifications

BS in relevant fieldMS in relevant fieldPhD in relevant fieldCertified Quality AuditorCertified Quality Engineer

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.