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Gilead Sciences

Makes medicines for HIV, liver disease and cancer

QA Specialist 3

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeLa Verne, CA, USAIn-person

About the Job

Requirements

  • A bachelor's degree in computer science and at least 6 years of relevant experience in a GMP-related field, or a master's degree and at least 4 years of relevant experience.
  • A computer science background with hands-on experience in backend development and coding practices.
  • Prior experience in the pharmaceutical or biopharmaceutical industry is preferred.
  • Strong knowledge of Good Manufacturing Practices (GMP) and quality systems is preferred.
  • Familiarity with Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS or GLIMS), and document management systems is preferred.
  • Proficiency in Microsoft Office applications is preferred.
  • SAP system development, coding, and/or validation experience is preferred.
  • Strong verbal communication, technical writing, and interpersonal skills are preferred.

Responsibilities

  • Serve as a Quality subject-matter expert for SAP Quality Management (QM) and Digital Quality solutions, translating GMP business needs into system requirements and process improvements.
  • Support SAP QM incident management, sustainment, and solution releases.
  • Drive standardization and optimization of quality processes, including material status, usage decision, and jurisdictional control.
  • Partner cross-functionally with Quality, Manufacturing, Supply Chain, and IT.
  • Support global deployments through testing, change management, documentation, and training.
  • Contribute to continuous improvement and key performance indicator (KPI)-based performance monitoring.
  • Perform activities to ensure compliance with applicable regulatory requirements.
  • Participate in developing Standard Operating Procedures to ensure quality objectives are met.
  • Facilitate external audits and inspection processes as an SAP subject-matter expert and support corrective action implementation as needed.
  • Assist with compliance audits as required.

Desired Qualifications

  • Prior experience in the pharmaceutical or biopharmaceutical industry.
  • Strong knowledge of Good Manufacturing Practices (GMP) and quality systems.
  • Familiarity with Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS or GLIMS), and document management systems.
  • Proficiency in Microsoft Office applications.
  • SAP system development, coding, and/or validation experience.

About the Company

Gilead Sciences

Makes medicines for HIV, liver disease and cancer

Gilead Sciences is a biopharmaceutical company that discovers, develops and sells medicines for HIV, viral hepatitis and other liver diseases, cancer and inflammatory conditions. Its HIV business covers both treatment, led by the once-daily pill Biktarvy, and prevention, including Descovy and Yeztugo, a lenacapavir injection given twice a year. In cancer, its Kite unit makes CAR T-cell therapies from patients' own immune cells, and Trodelvy is an antibody-drug conjugate for breast cancer. Gilead earns revenue by selling its drugs to wholesalers, specialty pharmacies, hospitals and governments worldwide after regulatory approval. The company was founded in 1987 and is headquartered in Foster City, California.

Company size
10,001+
Company stage
IPO
Headquarters
Foster City, CA
Founded
1987

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