Senior Quality Assurance Specialist

Job title: Senior Quality Assurance Specialist

About the Role At Gilead, the Senior Quality Assurance Specialist ensures quality and compliance in batch record review and product release, risk assessments, change control, and site audits. The role collaborates with internal partners to resolve quality issues and supports continuous improvement and inspection readiness.

What You'll Do

• Manage, prioritize, and participate in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products; responsibility for final release.
• Participate in introduction of new clinical/commercial products to the site.
• Participate in risk assessments.
• Author, review, and approve changes to SOPs, specifications, forms, and other controlled documents to ensure GMP compliance.
• Participate in site inspection readiness activities.
• Participate in internal and external audits as needed.
• Participate in continuous improvement initiatives.
• Support generation, and review of metrics and trending data.
• Partner with internal partners to resolve quality issues.
• Participate in review/approval of Deviations, CAPAs, and Change Management records.
• Address moderately complex problems requiring in-depth evaluation; exercise judgement in resolving issues and recommending scientific routine solutions.
• Perform activities to ensure compliance with quality objectives and regulatory requirements.

What We're Looking For

• Bachelor’s Degree and 6+ years of experience required OR Master’s Degree and 4+ years of experience required OR PhD or PharmD with 0+ years of experience.
• Experience with parenteral and aseptic operations; proficiency or familiarity with Annex 1 requirements.
• Experience across broad areas of Quality Assurance and/or Quality Systems.
• Experience with interacting with regulatory agencies.
• Excellent interpersonal, verbal, and written communication skills.
• Knowledge of Risk Management tools (e.g., HACCP and FMEA).

Nice to Have

• Advanced degree (Masters or PhD/PharmD) is preferred.
• Experience with batch record review and release of clinical and/or commercial product is preferred.
• Experience with medical devices is preferred.
• Experience with biological products.

Compensation & Benefits

• Salary range: $123,930.00 - $160,380.00 per year (USD).
• This position may 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.