Director, Product Quality - Small Molecules

Regulatory Jobs; Santa Monica (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

Gilead, a leader in developing therapies for HIV, hepatitis, COVID-19 and cancer, seeks a senior Quality & Regulatory leader to drive product quality strategy and risk-based decision making across development, manufacturing, analytical and regulatory functions.

You will lead cross-functional teams, author regulatory filings, oversee PQT activities, and ensure inspection readiness with a focus on balancing patient safety with business goals.

Qualifications

• Lead teams with scientific rigor in a matrix environment.
• Develop product quality strategies across lifecycle stages.
• Provide risk-based assessment of data and processes to support regulatory decisions.
• Champion regulatory filings and health authority interactions.
• Drive containment, IPCs, and comparability approaches with a data-driven mindset.
• Translate complex technical information for leadership and regulators.

Responsibilities

• Provide quality leadership on cross-functional teams in a matrix environment, driving alignment and decision making, performing a scientifically sound and risk-based evaluation of process and product quality data, and developing patient-oriented strategies
• Execute/drive product strategies through in-depth 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 product quality strategy, priorities, and deliverables across the product lifecycle.
• Through the product quality risk register, drive identification, assessment, and mitigation of product quality risks using a science- and risk-based approach.
• 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 controls, starting material, drug substance and drug product specifications, stability strategy, and comparability approaches.
• Author and approve regulatory filings associated with product quality 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 Senior Director, Product Quality Heads, as needed

Skills

People leadership

Quality systems knowledge

Regulatory filing experience

Cross-functional collaboration

Risk-based decision making

Scientific data analysis

Product quality strategy

Job description

Gilead, a leader in developing therapies for HIV, hepatitis, COVID-19 and cancer, seeks a senior Quality & Regulatory leader to drive product quality strategy and risk-based decision making across development, manufacturing, analytical and regulatory functions.

You will lead cross-functional teams, author regulatory filings, oversee PQT activities, and ensure inspection readiness with a focus on balancing patient safety with business goals.