Senior Director, Quality Control (QC Head)

Arbeitsbeschreibung

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Senior Director, Quality Control (QC Head) at Gilead, you will be responsible for providing strategic leadership and end-to-end oversight of Quality Control operations at the La Verne site across small molecule and biologics products.

This role is accountable for ensuring GMP compliance, inspection readiness, and robust analytical support for commercial manufacturing, pipeline advancement, and lifecycle management. The QC Head partners closely with site and global stakeholders to drive operational excellence, harmonization, and continuous improvement, while ensuring alignment with enterprise quality standards.

The position reports to the Site Head of Quality and is a key member of the site Quality Leadership Team.

This position requires a candidate to be based at our La Verne, CA facility.

Key Responsibilities

1. 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

2. 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

3. 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 and monitor QC performance metrics (KPIs) and drive continuous improvement, digitalization, and automation

• Partner cross-functionally (Manufacturing, MSAT, QA, Regulatory, Supply Chain) to ensure aligned execution and reliable product supply

Knowledge:

• Experience supporting commercial manufacturing, PPQ, and technical transfers, ensuring robust and reliable analytical support 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

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.