QA Specialist III

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

Responsibilities

• Provides direct QA oversight of clinical small molecule drug substance and oral solid dosage (OSD) pilot plant manufacturing, warehouse, and is responsible for product disposition utilizing risk-based and phase appropriate approach.
• Reviews and approves manufacturing documentation which may include batch records, product release documentation, deviations, investigations (i.e. OOS, OOT, atypical), CAPAs, change controls, protocols and reports.
• Maintains accurate, complete, and timely (ALCOA) quality records in accordance with GMP and quality systems.
• Supports QA team members in daily operations such as lot disposition and process improvement projects.
• Participates in departmental and cross-functional projects, delivering assigned QA deliverables in compliance with quality systems.
• Supports small to moderately complex process improvement projects.
• Applies root cause analysis and uses risk-based thinking to support investigations and quality events.
• Helps identify data trends, anomalies, and potential compliance risks and escalates appropriately.
• Leads revisions of GMP documentation to support QA projects.
• Creates metrics and reports as needed.
• Supports regulatory inspections, internal audits, including preparation, execution, and observation response generation.
• Assists junior staff with day-to-day tasks as an SME.
• Authors, reviews SOPs, protocols, reports and other GMP documentation.

Requirements

• Demonstrates proficiency in Good Manufacturing Practices (GMPs).
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
• Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
• Demonstrates a basic understanding of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations.
• Demonstrates audit and investigation skills, and report writing skills.
• Demonstrates strong verbal, technical writing and interpersonal skills.
• Demonstrates proficiency in Microsoft Office applications.

Qualifications

• 5+ years of relevant experience in a GMP environment related field and a BS or BA.
• OR 3+ years of relevant experience and an MS.
• Prior experience in pharmaceutical industry is preferred.

Pay

The salary range for this position is $117,895.00 - $152,570.00. 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

• 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. For additional benefits information, visit Gilead Benefits.