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

Job Description

The responsibilities of the Senior QA Specialist are to maintain commercial product specifications current in all GMP systems, as well as manage the SAP workflow to ensure compliance to product dossiers and enable timely release of products. Lifecycle management of specifications includes revisions based on feedback from health authorities during post‑approval changes and submission of commercial products to additional countries, or from continuous process verification where a change to approved specification is warranted.

The Senior QA Specialist must manage the change control record in GVault pertaining to specification revision and must be well versed in using the SAP system. Knowledge of specification setting and experience with assisting the response to health authority inquiries related to specifications are beneficial.

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

• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Participates in writing or suggesting changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed, to ensure defined quality objectives are met.
• Maintains programs and processes to ensure high‑quality products and compliance with current Good Manufacturing Practices (GMPs).
• May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
• May assist or lead compliance audits as required.
• May interface with regulatory agencies as required.
• Interfaces with internal sites and contract manufacturers to address inquiries from health authorities during product submission and post‑approval changes.

• Proficient in application of QA principles, concepts, industry practices, and standards.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Has proven analytical and conceptual skills.
• Demonstrates understanding of international quality systems regulations to adopt best‑in‑class systems/processes.
• Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Demonstrates working knowledge and good proficiency in Microsoft Office applications.
• Knowledge of Six Sigma, Define‑Measure‑Analyze‑Improve‑Control (DMAIC) methodology, performance measures and quality improvement statistical methods is beneficial.
• Working knowledge of risk‑management tools (e.g., HACCP and/or FMEA) is beneficial.
• Knowledge with IND/NDA/BLA submission process is desired.

The salary range for this position is $ – $. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, 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'…