Director, QC Technology & Innovation

Gilead Sciences•La Verne, CA

1d•$191,250 - $247,500

About The Position

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. The role drives adoption and implementation of new instruments, testing technologies, digital solutions, and automation while strengthening scientific understanding and robustness of analytical methods. It leads analytical method transfers and complex technical troubleshooting so QC capabilities can evolve with the site’s portfolio and business needs. The Director advances QC toward a highly automated, digitally integrated, and low-touch laboratory environment using emerging analytical technologies, automation, robotics, and innovative testing approaches. The role partners with global and site stakeholders to implement QC technology strategy in alignment with global quality strategies, enterprise priorities, network standards, and future-state roadmaps. The position leads analytical method transfers supporting new product introduction, PPQ, commercial manufacturing, and product lifecycle changes; evaluates readiness, technical risks, instrumentation, laboratory capability, and training; and provides technical leadership for validation, verification, transfer, and implementation. It also serves as a senior technical expert for analytical methods and instrumentation, leading complex troubleshooting and laboratory investigations, including OOS/OOT and method performance issues. The Director assesses future analytical and technology needs across small molecule and biologics portfolios, identifies capability gaps, drives continuous improvement, establishes performance metrics, and builds technical capability through coaching and knowledge sharing. The position is based in La Verne, California.

Requirements

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

Nice To Haves

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

Responsibilities

Lead implementation of the site QC technology and innovation strategy in collaboration with Global Quality, aligning with global digital and innovation strategies, 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.
Develop and maintain a future-state QC technology roadmap aligned with global vision and roadmaps, enabling increasingly automated, integrated, and low-touch testing.
Identify opportunities to automate end-to-end analytical workflows, reduce manual interventions and handoffs, and improve data flow and testing efficiency.
Lead proof-of-concept studies and technical assessments for emerging technologies with global subject matter experts, sharing results to support coordinated investment and scalable adoption.
Modernize and simplify laboratory testing using network standards, shared capabilities, and best practices to improve efficiency, reliability, and analytical capability.
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 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.
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.
Use 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.
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.