Sr Director, Quality Control

Gilead Sciences • La Verne, CA

8d

About The Position

The Sr Director, Quality Control will lead all site Quality Control functions and set the site QC strategy in alignment with global quality and business objectives. The role oversees analytical, microbiology, raw materials, in-process, drug substance, drug product, and stability programs across small molecule and biologics platforms. It ensures QC supports commercial manufacturing, PPQ, technical transfers, and new product introduction while meeting global GMP requirements and maintaining inspection readiness.

The role builds technical capability across the QC organization, including analytical expertise, method lifecycle management, and adoption of advanced technologies. It establishes capability development strategies covering training, knowledge management, and technical succession planning, and leads a high-performing organization focused on scientific rigor, continuous learning, collaboration, accountability, and engagement.

The position contributes to global QC network harmonization and enterprise initiatives, drives adoption of global policies and best practices, and partners with global QC leadership and cross-site teams. It leads Lean Laboratory practices and sets strategic direction for QC technology, innovation, digitalization, automation, and continuous improvement. The role works cross-functionally with Manufacturing, MSAT, QA, Regulatory, and Supply Chain to support aligned execution and reliable product supply.

Requirements

• Bachelor’s degree in a scientific discipline and 14 or more years of experience in the pharmaceutical or biopharmaceutical industry, including significant leadership experience in Quality Control in a GMP-regulated environment; OR a master’s or PhD in a scientific discipline and 12 or more years of relevant industry experience, including significant QC leadership experience in a GMP-regulated environment.
• Deep expertise in analytical sciences and Quality Control across small molecule and biologics, with recognized technical leadership.
• 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 skills across teams.
• Strong knowledge of global GMP regulations, inspection management, and data integrity (ALCOA+), with a track record supporting FDA, EMA, and PMDA regulatory inspections.
• Demonstrated ability to drive Lean Laboratory principles and continuous improvement, including process optimization, digitalization, and automation to improve laboratory efficiency and performance.
• Experience providing strategic oversight for commercial manufacturing, PPQ, new product introduction, and method transfers, with robust analytical capabilities 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 and make effective, 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, including the ability to influence at site and executive levels.

Nice To Haves

• A master’s or PhD (advanced degree) in a scientific discipline is preferred.

Responsibilities

• Lead and oversee site QC 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 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, maintaining compliance and data integrity standards.
• Strengthen technical capabilities, analytical expertise, method lifecycle management, and adoption of advanced technologies across QC.
• Establish capability-development strategies, including structured training, knowledge management, and technical succession planning.
• Build, develop, and lead a high-performing QC organization with strong engagement and accountability.
• Foster a culture of scientific rigor, continuous learning, collaboration, and accountability.
• Lead or contribute to QC network harmonization and global initiatives, and drive adoption of global QC policies, systems, and best practices.
• Partner with global QC leadership and cross-site teams to enable standardization and capability building.
• Lead and embed Lean Laboratory principles to improve workflow efficiency, reduce waste, and enhance throughput.
• Set strategic direction for QC technology, innovation, digitalization, automation, and continuous improvement.
• Partner with Manufacturing, MSAT, QA, Regulatory, and Supply Chain to enable aligned execution and reliable product supply.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical, dental, vision, and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director