Director, Product Quality Leader, Biologics

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

Job Functions:

• 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 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.
• 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 control, starting material, drug substance and drug product specifications, stability strategy, and comparability approaches.
• Reviewand 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 Commercial Product Quality Head, as needed

Knowledge, Experience and Skills:

• 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.

Basic Qualifications:

• Prior Quality leadership and technical management experience in development and/or commercial programs.

…