Senior Director, Quality Control (QC Head)

Responsibilities

• Provide strategic leadership and end-to-end oversight of Quality Control operations at the La Verne site for small molecule and biologics products.
• Lead all QC functions including analytical, microbiology, raw materials, in-process, drug substance, drug product, and stability programs.
• Ensure continuous GMP compliance and inspection readiness, representing the site during regulatory audits (FDA, EMA, PMDA).
• Build and strengthen technical capabilities, including method lifecycle management and the adoption of advanced technologies.
• Drive Lean Laboratory principles to improve workflow efficiency, reduce waste, and enhance throughput.
• Partner with global QC leadership to drive network harmonization and alignment with enterprise quality standards.
• Lead and develop a high-performing QC organization through structured training, knowledge management, and succession planning.

Requirements

• Bachelor's degree in a scientific discipline and 14+ years of experience in the pharmaceutical/biopharmaceutical industry.
• OR Master's degree in a scientific discipline and 12+ years of experience in the pharmaceutical/biopharmaceutical industry.
• OR PhD in a scientific discipline and 12+ years of experience in the pharmaceutical/biopharmaceutical industry.
• Significant leadership experience in Quality Control within a GMP-regulated environment.
• Deep expertise in analytical sciences across both small molecule and biologics platforms.
• Proven track record of managing regulatory inspections and maintaining high data integrity standards (ALCOA+).
• Demonstrated ability to lead large teams and drive continuous improvement through digitalization and automation.

Preferred Qualifications

• Advanced degree (MS or PhD) in a scientific discipline.
• Experience supporting commercial manufacturing, PPQ, and technical transfers.
• Experience leading global QC initiatives and cross-site collaboration efforts.

About the Company

Gilead is a research-based biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years. We work relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.