Director, QC Technology & Innovation

Director, QC Technology & Innovation, La Verne, CA

Position Summary

The Director, QC Technology & Innovation reports to the Site QC Head and provides scientific and technical leadership for QC technology, analytical methods, method transfer, and laboratory innovation.

This role is responsible for driving the adoption and implementation of new instruments, testing technologies, digital solutions, and automation, while strengthening the scientific understanding and robustness of analytical methods. The Director will also lead analytical method transfers and complex technical troubleshooting to ensure QC capabilities evolve with the site’s portfolio and business needs.

The role will advance QC toward a highly automated, digitally integrated, and low-touch laboratory environment, leveraging emerging analytical technologies, automation, robotics, and innovative testing approaches.

Core Accountabilities

1. Technology & Innovation

• Lead implementation of the site QC technology and innovation strategy in collaboration with Global Quality, ensuring alignment with the Global Quality Digital and Innovation Strategy, enterprise priorities, and future-state vision.
• Collaborate with global and site stakeholders to identify, evaluate, and implement laboratory instruments, analytical technologies, automation, digital solutions, and testing approaches that align with global strategies and standards.
• Develop and maintain a future-state QC technology roadmap aligned with the global vision and roadmaps, progressively enabling automated, integrated, and low-touch testing across the network.
• Partner across site and global functions to identify opportunities to automate end-to-end analytical workflows, reduce manual interventions and handoffs, and improve data flow and testing efficiency in alignment with global process and digital strategies.
• Lead proof-of-concept studies and technical assessments for emerging technologies in collaboration with global subject matter experts, sharing outcomes to support coordinated investment and scalable adoption.
• Drive modernization and simplification of laboratory testing in alignment with the global quality vision, leveraging network standards, shared capabilities, and best practices to improve efficiency, reliability, and analytical capability.

2. Method Transfer & New Product Introduction

• Lead analytical method transfers supporting new product introduction, PPQ, commercial manufacturing, and product lifecycle changes.
• Assess method readiness, technical risks, instrumentation requirements, laboratory capability, and training needs.
• Provide technical leadership for method validation, verification, transfer, and implementation.
• Partner closely with MSAT, QA, Regulatory CMC, Manufacturing, and sending units to ensure successful method transfer.
• Ensure transferred methods are scientifically sound, robust, and suitable for routine GMP testing.

3. Analytical Science & Technical Troubleshooting

• Serve as a senior technical expert for analytical methods, testing technologies, and laboratory instrumentation.
• Lead resolution of complex analytical, method, and instrument-related issues.
• Provide technical leadership for complex laboratory investigations, including OOS/OOT and method performance issues.
• Apply science-based problem solving and experimental design to identify root causes and develop sustainable solutions.
• Strengthen scientific understanding, critical thinking, and technical problem-solving capability across QC.

4. QC Capability & Continuous Improvement

• Assess future analytical and technology needs across small molecule and biologics portfolios.
• Identify capability gaps and develop solutions related to instrumentation, methods, technology, and technical expertise.
• Drive continuous improvement of analytical methods and laboratory technologies.
• Establish appropriate metrics for method transfer, technology implementation, and technical performance.
• Build technical capability through coaching, knowledge sharing, and development of subject matter experts.

Qualifications

• Strong technical expertise in QC analytical methods, laboratory instrumentation, and analytical technologies.
• Demonstrated experience in analytical method transfer, validation, implementation, and lifecycle management.
• Proven ability to lead complex technical troubleshooting and laboratory investigations using sound scientific principles.
• Experience evaluating and implementing new analytical technologies, automation, robotics, and digital laboratory solutions.
• Experience supporting commercial manufacturing, PPQ, and new product introduction in a GMP environment.
• Strong knowledge of GMP requirements, data integrity, and regulatory expectations for QC laboratories.
• Strong cross-functional leadership, communication, and problem-solving skills.

Required Education/Experience

• BS in a scientific discipline with 12+ years of relevant pharmaceutical/biopharmaceutical experience; or
• MS with 10+ years of relevant experience; or
• PhD with 8+ years of relevant experience.
• Significant experience in QC, Analytical Sciences, Analytical Development, or a related GMP laboratory function.

Preferred

• Advanced degree in a scientific discipline.
• Experience with both small molecule and biologics analytical technologies.
• Experience implementing advanced laboratory automation or innovative testing technologies.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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