Sr Director, Quality Control

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

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

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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