Director, Product Quality Lead (PQL), Small Molecule Global Quality

About the role

Gilead is seeking a Product Quality Lead (PQL) to serve as the single point of contact for product quality, providing technical, scientific, and strategic expertise to the Product CMC/Product Development and Manufacturing Team and the Product Quality Team during clinical development through commercialization. The PQL will define the product quality and compliance strategy, own end-to-end product quality deliverables, and proactively identify and mitigate product risks to ensure continuous improvement throughout the product lifecycle. This role supports cross-functional initiatives to strengthen compliance, enhance product quality, and enable robust lifecycle management, while serving as the primary Quality interface for alliance management and due diligence activities.

Responsibilities

• Provide quality leadership on cross-functional teams in a matrix environment, driving alignment and decision-making, and performing scientifically sound, risk-based evaluations of process and product quality data.
• Execute and drive product strategies using strong quality and scientific knowledge related to product development, technology transfers, global regulatory filing strategies, analytical methods, stability, drug substance and drug product specifications, and In-Process Controls (IPCs).
• Lead Product Quality Team (PQT) activities to align on product quality strategy, priorities, and deliverables across the product lifecycle.
• Drive identification, assessment, and mitigation of product quality risks using a science- and risk-based approach through the product quality risk register.
• Monitor and review cross-functional process and product data to identify trends and ensure quality and compliance risks are proactively addressed and escalated as needed.
• Lead the development of control strategies, including in-process control, starting material, drug substance and drug product specifications, stability strategy, and comparability approaches.
• Review and approve regulatory filings and support responses to health authority questions.
• Provide cross-functional guidance to align product quality strategy across development, manufacturing, analytical, and regulatory stakeholders.
• Assess product quality impact for changes, deviations, and events, and ensure appropriate implementation plans are developed.
• Support drug substance and drug product technology transfer and new product launches.
• Ensure inspection readiness, including PAI/PLI preparation through participation as a product expert.
• Apply science- and risk-based evaluation to complex issues and develop practical, patient-focused solutions that balance quality, regulatory expectations, and business needs.
• Communicate complex quality and technical information clearly to leadership, cross-functional teams, and regulatory agencies.
• Act as delegate to the Commercial Product Quality Head as needed.

Requirements

• In-depth understanding of cGMP principles and applicable regulatory guidelines and directives (e.g., ICH, EP, JP, USP, 21 CFR).
• Demonstrated experience applying science- and risk-based approaches to product quality, including control strategy, comparability, and lifecycle management.
• Solid knowledge of drug substance and drug product development, manufacturing processes, and associated quality considerations.
• Experience working in cross-functional teams within a matrix environment, with the ability to influence decisions without direct authority.
• Proven ability to lead or contribute to complex product/program activities, including regulatory filings, product quality assessments, and lifecycle management.
• Experience supporting inspections (e.g., PAI/PLI) and interacting with regulatory agencies.
• Strong technical and analytical skills, with the ability to interpret complex product and process data and translate insights into risk-based decisions.
• Ability to identify, assess, and communicate product quality risks and drive appropriate mitigation strategies.
• Effective problem-solving skills, including developing practical, patient-focused solutions to complex quality issues.
• Strong written and verbal communication skills, with the ability to clearly convey complex quality and technical information to cross-functional teams, leadership, and regulatory agencies.
• Ability to operate independently, manage multiple priorities, and make sound decisions in a fast-paced environment.

Qualifications

• Prior Quality leadership and technical management experience in development and/or commercial programs.
• 12+ years of relevant experience and a bachelor’s degree in science or related fields; or 10+ years of relevant experience and an advanced science degree such as MS, PharmD, or PhD.
• Demonstrated experience and knowledge in quality in a highly regulated manufacturing environment.
• Direct experience with regulatory health authority submissions (e.g., IND, NDA, BLA, MAA) and/or inspections.
• Broad experience across several areas including analytical product characterization, process validation, drug development experience, and packaging/labeling.

Preferred Qualifications

• 5+ years working in a regulated environment (either direct GMP or technical support).
• Excellent interpersonal, verbal, and written communication skills, including facilitation and presentation skills.
• Ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
• Must be able to work on multiple projects simultaneously and demonstrate ability to organize, prioritize, and manage time.
• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
• Experience authoring or reviewing BLA/MAAs, INDs/IMPDs, supplements/variations, or similar regulatory documentation.
• Experience supporting non-conformance investigations, authoring, reviewing, and defending critical product-impacting non-conformances.

Pay

The salary range for this position is $210,375.00 – $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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

• Company-sponsored medical, dental, vision, and life insurance plans.
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.