Sr Director, Quality Control

Key Responsibilities

• QC Strategy & Operations
• Lead and oversee all Quality Control functions at the site, 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, aligned with global quality and business objectives
• Ensure effective support of commercial manufacturing, PPQ, technical transfers, and new product introduction
• Ensure QC operations meet global GMP requirements and maintain a continuous state of inspection readiness
• Represent QC during regulatory inspections and audits, ensuring strong compliance and data integrity standards
• Technical Capability Strengthening & People Leadership
• Build and strengthen technical capabilities across the QC organization, including analytical expertise, method lifecycle management, and adoption of advanced technologies
• Establish and drive 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 quality culture emphasizing scientific rigor, continuous learning, collaboration, and accountability
• Ensure the organization is equipped to support evolving portfolio needs across small molecule and biologics
• Global Alignment, Lean Labs & Continuous Improvement
• Contribute to and lead QC network harmonization and global initiatives, ensuring alignment with enterprise standards and practices
• Drive adoption of global QC policies, systems, and best practices at the site
• 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
• Establish the strategic direction for QC technology, innovation, digitalization, automation, and continuous improvement
• Partner cross-functionally (Manufacturing, MSAT, QA, Regulatory, Supply Chain) to ensure aligned execution and reliable product supply

Knowledge

• Experience providing strategic oversight for commercial manufacturing, PPQ, new product introduction, and method transfers, ensuring robust analytical capabilities across the product lifecycle
• Experience contributing to or leading global QC initiatives, network harmonization, and cross-site collaboration efforts, with an enterprise mindset
• Proven ability to balance technical rigor, compliance, and business needs, ensuring effective and timely decision-making
• Strong people leadership and talent development capabilities, including building high-performing teams, developing future leaders, and strengthening organizational capability
• Excellent cross-functional leadership, communication, and stakeholder engagement skills, with the ability to influence at both site and executive levels

Required

• Bachelor's degree in a scientific discipline and 14+ years of experience in the pharmaceutical or biopharmaceutical industry, with significant leadership experience in Quality Control within a GMP-regulated environment required OR
• Masters degree in a scientific discipline and 12+ years of experience in the pharmaceutical or biopharmaceutical industry, with significant leadership experience in Quality Control within a GMP-regulated environment required OR
• PhD in a scientific discipline and 12+ years of experience in the pharmaceutical or biopharmaceutical industry, with significant leadership experience in Quality Control within a GMP-regulated environment required
• Recognized technical leader with deep expertise in analytical sciences and Quality Control across small molecule and biologics, and a demonstrated ability to make sound, science-based decisions in complex and ambiguous situations
• Proven experience building and leading strong, technically capable QC organizations, with a focus on developing scientific depth, critical thinking, and problem-solving capabilities across teams
• Strong knowledge of global GMP regulations, inspection management, and data integrity (ALCOA+), with a proven track record supporting regulatory inspections (FDA, EMA, PMDA)
• Demonstrated ability to drive Lean Laboratory principles and a continuous improvement mindset, including process optimization, digitalization, and automation to enhance lab efficiency and performance

Preferred

• MS, PhD (advanced degree) in a scientific discipline preferred

Pay and benefits

The salary range for this position is: $221,000.00 - $286,000.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit

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

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For Current Gilead Employees and Contractors

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