QA Senior Specialist - External Quality, Strategy, Processes and Metrics

QA Senior Specialist – External Quality, Strategy, Processes and Metrics

Join Gilead Sciences as a QA Senior Specialist focused on ensuring compliance with GMP and regulatory standards for commercial products.

• Maintain commercial product specifications current in all GMP systems.
• Manage SAP workflow to ensure compliance to product dossiers and enable timely release of products.
• Handle lifecycle management of specifications, including revisions based on health‑authority feedback and post‑approval changes.
• Manage change control records in GVault pertaining to specification revision.
• Assist in responding to health‑authority inquiries related to specifications.

• 7+ years of relevant experience in a GMP environment.
• BS or BA degree.
• 5+ years of relevant experience and an MS degree.

• Experience writing or suggesting changes to controlled documents such as SOPs, specifications, and methods.
• Maintain programs and processes ensuring high‑quality products and GMP compliance.
• Ability to write annual product reviews and develop training programs.
• Experience with compliance audits and interface with regulatory agencies.
• Interface with internal sites and contract manufacturers for health‑authority inquiries.
• Proficient in QA principles, concepts, industry practices, and standards.
• Strong project management and analytical skills.
• Understanding of international quality systems regulations.
• Excellent verbal, technical writing and interpersonal communication skills.
• Proficient in Microsoft Office.
• Knowledge of Six Sigma and DMAIC methodology beneficial.
• Knowledge of HACCP and/or FMEA beneficial.
• Knowledge of the IND/NDA/BLA submission process desired.

Salary range: $ – $. Additional discretionary annual bonus, stock‑based incentives, paid time off, and a benefits package including medical, dental, vision, and life insurance. For additional benefits information, visit

Gilead Sciences Inc. is committed to equal employment opportunities and fostering an inclusive environment. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, gender identity, veteran status, or other non‑job related characteristics, in compliance with applicable laws. Reasonable accommodations may be provided. For more information, view the “Know Your Rights” poster.

Seniority level:
Not applicable

Employment type:

Full‑time