Sr Director, Quality Control

Gilead Sciences•La Verne, CA

9d•$221,000 - $286,000

About The Position

Gilead is seeking a senior Quality Control leader to oversee site QC functions and set the site QC strategy in alignment with global quality and business objectives. The role supports commercial manufacturing, process performance qualification (PPQ), technical transfers, and new product introduction across small molecule and biologics platforms, while ensuring GMP compliance, inspection readiness, and data integrity. The Sr Director will strengthen QC technical capabilities and lead a high-performing organization through training, knowledge management, succession planning, and talent development. The role also contributes to global QC harmonization, promotes Lean Laboratory principles, and establishes strategic direction for QC technology, innovation, digitalization, automation, and continuous improvement. Close partnership with Manufacturing, MSAT, QA, Regulatory, Supply Chain, and global QC teams is expected to support aligned execution and reliable product supply.

Requirements

Bachelor’s degree in a scientific discipline and 14 or more years of pharmaceutical or biopharmaceutical industry experience, including significant leadership experience in Quality Control in a GMP-regulated environment; alternatively, a master’s or PhD in a scientific discipline and 12 or more years of relevant industry experience with significant QC leadership experience.
Recognized technical leader with deep expertise in analytical sciences and Quality Control across small molecule and biologics.
Ability to make sound, science-based decisions in complex and ambiguous situations.
Proven experience building and leading technically capable QC organizations and developing scientific depth, critical thinking, and problem-solving across teams.
Strong knowledge of global GMP regulations, inspection management, and ALCOA+ data integrity.
Track record supporting regulatory inspections, including FDA, EMA, and PMDA.
Demonstrated ability to drive Lean Laboratory principles and continuous improvement, including process optimization, digitalization, and automation to improve laboratory efficiency and performance.
Strategic oversight experience supporting commercial manufacturing, PPQ, new product introduction, and method transfers across the product lifecycle.
Experience contributing to or leading global QC initiatives, network harmonization, and cross-site collaboration.
Ability to balance technical rigor, compliance, and business needs while making effective and timely decisions.
Strong people leadership and talent development capabilities, including building high-performing teams and developing future leaders.
Excellent cross-functional leadership, communication, and stakeholder engagement skills, with ability to influence at site and executive levels.

Nice To Haves

Master’s or PhD (advanced degree) in a scientific discipline is preferred.

Responsibilities

Lead and oversee site Quality Control functions, including analytical, microbiology, raw materials, in-process, drug substance, drug product, and stability programs across small molecule and biologics platforms.
Define and execute the site QC strategy in alignment with global quality and business objectives.
Ensure effective QC support for commercial manufacturing, PPQ, technical transfers, and new product introduction.
Ensure QC operations meet global GMP requirements and maintain inspection readiness.
Represent QC during regulatory inspections and audits, ensuring compliance and data integrity.
Build and strengthen QC technical capabilities, including analytical expertise, method lifecycle management, and adoption of advanced technologies.
Establish and drive capability development through structured training, knowledge management, and technical succession planning.
Build, develop, and lead a high-performing QC organization, fostering engagement, accountability, scientific rigor, continuous learning, and collaboration.
Contribute to and lead QC network harmonization and global initiatives, and drive adoption of global QC policies, systems, and best practices at the site.
Lead and embed Lean Laboratory principles to improve workflow efficiency, reduce waste, and enhance throughput.
Establish strategic direction for QC technology, innovation, digitalization, automation, and continuous improvement.
Partner with global QC leadership, cross-site teams, Manufacturing, MSAT, QA, Regulatory, and Supply Chain to support standardization, capability building, aligned execution, and reliable product supply.