Job Description

About Gilead

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.

Overview

We are seeking a highly motivated individual to join the Internal Quality Strategy and Operations team. The successful candidate will lead instrument control and data acquisition management for complex analytical instruments supporting both small molecule and biologics within Quality Control. These capabilities include chromatography, microplate readers, mass spectrometry, endotoxin testing, titration, particle size analysis, Mettler-Toledo instrument data acquisition, x-ray diffraction, thermal analysis, nuclear magnetic resonance, and their associated instrument control and processing software. Generally complex instruments such as these are categorized as Group C instruments according to USP 1058, Analytical Instrument Qualification and used as a framework for establishing fitness for intended use.

Candidate will lead a team that manages implementation, qualification, ongoing operations, enhancements, decommissioning, and retirement of these complex analytical instruments, their associated instrument control software and data following health authority regulatory compliance and data integrity requirements. The team is responsible for ensuring all changes are controlled and properly managed. Together the team supports the development and implementation of workflows to automate laboratory processes towards improved efficiency, compliance, and transform processes through innovative solutions. In addition, embracing emerging technologies including AI, and championing data-driven, digitally empowered ways of working is critical for success.

This position reports to the Executive Director of Internal Quality Strategy and Operations and partners closely with Quality leadership, Technical Development, IT, Manufacturing, CMC Regulatory, Finance, Procurement, and the broader Gilead ecosystem. This role will sit in Foster City, CA.

Key Responsibilities

Leadership and Management of Complex Analytical Instruments

• Knowledge and expertise of various instrument and their software including chromatography, microplate readers, mass spectrometry, endotoxin testing, titration, particle size analysis, Mettler-Toledo instrument data acquisition, x-ray diffraction, thermal analysis, nuclear magnetic resonance, optical rotation, infrared spectroscopy, disintegration
• Understanding of USP 1058, Analytical Instrument Qualification and its application
• Responsible for Instrument control and data acquisition software such as Waters Empower, Mettler Toledo LabX, Softmax Pro, Mass Hunter, OMNIC Paradigm, OPUS, TRIOS, Tiamo
• Maintain quality and compliance of instruments including data integrity, GMP adherence, and right-first-time execution
• Lead the business case development and ROI analysis for new complex instrument investments, effectively communicating trade-offs between speed, cost, and scope to leadership and stakeholders

GMP Compliance, Program Delivery, Vendor Coordination, Always Inspection Ready

• Critical thinking and analysis of overall instrument landscape, processes, metrics, pain points, and opportunities for improvement
• Deliver GMP analytical instruments and associated instrument control software to quality laboratories in a timely manner, with documentation, procedures, qualification, processes meeting their intended use
• Ensure instruments are highly available for testing to scientists and in a compliant state
• Foster relationships and work with major instrument and equipment vendors such as Waters, Thermo Fisher, Agilent, Mettler Toledo
• Responsible for quality records associated with complex instrument deviations, change controls, corrective and preventative actions meeting closure timeline expectations and quality resolution
• Represent management and compliance of complex instruments during inspections

Innovation, Change Leadership, and Continuous Improvement

• Continuously refine quality operations strategy and roadmap aligned to organizational priorities and enterprise platforms
• Communicate to leadership, peers, laboratory community and stakeholders information such as utilization, reliability, maintenance, inventory
• Continually assess, review, analyze, and develop strategy and plans for complex analytical instrument management across Gilead internal laboratories. Look at process flow and efficiency such as flow, queue times, handoffs, and bottlenecks
• Leverage advanced analytics to transform the ways of working and drive data-centric solutions, and look for opportunities for the practical use of AI
• Engage with instrument vendors and industry to stay on top of emerging and next generation analytical instruments
• Partner with IT and Technical Development to identify, evaluate, and create strategic partnerships with established and emerging instrument technology providers to bring cutting-edge solutions and expertise into the organization
• Lead change management, including upskilling, communication planning, and user adoption
• Partner with broader quality leadership and QC laboratory community to identify areas to remove friction or enable leapfrog innovation

Collaboration and Influence

• Serve as a bridge between Internal Quality stakeholders, QC lab personnel, QA to enable product release, support filings, and stability programs
• Partners closely with Technical Development, IT, Manufacturing, CMC Regulatory, Finance, Procurement
• Foster relationships with internal partners (e.g., IT, CMC RA) and external vendors
• Represent Internal Quality in steering committees and structured content working groups
• Align efforts with QC lab testing, drug development programs and instrument needs, data governance, instrument harmonization and standardization initiatives

Leadership & People Development

• Champion a safety mindset protecting employees, samples, and facilities
• Create a collaborative and inclusive work environment, promoting teamwork and effective communication
• Lead, mentor, and develop a high-performing team ensuring training, role clarity, engagement, and workload balance
• Implement visual management, KPIs, use proper escalation processes, and continuous improvement mindset

Qualifications

Basic Qualifications

• Bachelor's Degree and Twelve Years' Experience OR Masters' Degree and Ten Years' Experience OR Ph

D and Eight Years' Experience:

Preferred Qualifications

• Hands-on laboratory experiences and analytical instrument use preferred
• At least 5 years in leadership role managing teams across QC, lab operations, instrument and equipment management, informatics, data management
• Proven experience integrating instrument lifecycle, data and digital tools into workflows

Technical & Strategic Skills

• Demonstrated enterprise mindset with ability to align Quality needs to enterprise platforms and solutions, ensuring scalability, interoperability, and long-term business value
• Proven success leading instrument initiatives from strategy through implementation