Summary

Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.

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

Requirements

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
OR Master's 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
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
Recognized technical leader with deep expertise in analytical sciences and Quality Control across small molecule and biologics
Demonstrated ability to make sound, science-based decisions in complex and ambiguous situations
Proven experience building and leading strong, technically capable QC organizations
Strong knowledge of global GMP regulations, inspection management, and data integrity (ALCOA+)
Proven track record supporting regulatory inspections (FDA, EMA, PMDA)
Demonstrated ability to drive Lean Laboratory principles and a continuous improvement mindset
MS, PhD (advanced degree) in a scientific discipline preferred

Benefits

Medical, Dental & Vision
Life Insurance
Paid Time Off
Annual Bonus
Stock-Based Long-Term Incentives

Company overview

Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.