Director, Product Quality Small Molecule

Regulatory Toolkit; Santa Monica (CA); Presencial; USD 180.000 - 260.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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

Conocimientos

People leadership

Quality systems knowledge

Regulatory filing experience

Cross-functional collaboration

Risk-based decision making

Scientific data analysis

Product quality strategy

Descripción del empleo

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.

Job Description

• 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