QA Specialist II

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. 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.

About the role

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. This role supports QA oversight of clinical small molecule drug substance and oral solid dosage (OSD) pilot plant manufacturing, warehouse, and is responsible for product disposition utilizing a risk-based and clinical phase appropriate approach.

Responsibilities

• 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 team 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.
• Executes basic 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 revision of GMP documentation to support QA projects.
• Creates metrics and reports under the supervision of senior QA team members.
• Supports regulatory inspections, internal audits, including preparation, execution, and observation response generation.

Requirements

• Demonstrates working knowledge of current Good Manufacturing Practices (cGMPs).
• Demonstrates working knowledge of quality assurance systems, methods and procedures.
• Demonstrates knowledge of FDA / EMEA standards and quality systems.
• Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting causes of deviations.
• Demonstrates good verbal, written, and interpersonal communication skills.
• Demonstrates proficiency in Microsoft Office applications.

Qualifications

• 4+ years of relevant experience in a GMP environment related field and a BS.
• OR 2+ years of relevant experience and a MS.
• Prior experience in pharmaceutical industry is preferred.

Pay

The salary range for this position is $102,085.00 - $132,110.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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 Compensation, Benefits and Wellbeing.