Director, Product Quality Leader, Biologics

Gilead Sciences•Foster City, CA

About The Position

Gilead is hiring a Director, Product Quality Leader, Biologics, to provide product quality leadership across cross-functional teams in a matrix environment. The role evaluates process and product quality data using scientifically sound, risk-based approaches and develops patient-oriented strategies across the product lifecycle. It leads Product Quality Team activities, aligns quality priorities and deliverables, and drives identification, assessment, and mitigation of quality risks. The position leads development of product control strategies and supports product development, technology transfers, global regulatory filings, analytical methods, stability, specifications, and in-process controls. It reviews and approves regulatory filings, supports health authority responses and inspections, contributes to technology transfers and launches, and assesses quality impacts of changes, deviations, and events. The Director communicates complex technical and quality information to leadership, cross-functional teams, and regulators, and may act as delegate to the Commercial Product Quality Head.

Requirements

Prior Quality leadership and technical management experience in development and/or commercial programs.
At least 12 years of relevant experience with a bachelor's degree in science or a related field, or at least 10 years of relevant experience with an advanced science degree such as an 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, packaging/labeling, and understanding of parenteral, oral solid dosage, and biologics.
In-depth understanding of cGMP principles and applicable regulatory guidelines and directives, such as ICH, EP, JP, USP, and 21 CFR.
Demonstrated experience applying science- and risk-based approaches to product quality, including control strategy, comparability, and lifecycle management.
Knowledge of drug substance and drug product development, manufacturing processes, and associated quality considerations.
Experience working in cross-functional teams in a matrix environment and influencing 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 such as PAI/PLI and interacting with regulatory agencies.
Strong technical and analytical skills, including interpreting complex product and process data and translating 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, including 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.

Nice To Haves

At least 5 years working in a regulated environment, either in direct GMP work or technical support.
Excellent interpersonal, verbal, and written communication skills, including facilitation and presentation skills.
Ability to communicate complex ideas succinctly and clearly to a variety of audiences.
Ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
Ability to work on multiple projects simultaneously and organize, prioritize, and manage time effectively.
Comfort working in a fast-paced company environment with minimal direction and adjusting workload based on changing priorities.
Experience authoring or reviewing BLA/MAAs, INDs/IMPDs, supplements/variations, or similar regulatory documentation.
Experience supporting non-conformance investigations and authoring, reviewing, and defending critical product-impacting non-conformances.

Responsibilities

Provide quality leadership on cross-functional teams, supporting alignment, decision-making, and risk-based evaluation of process and product quality data.
Execute and drive product strategies for development, technology transfers, global regulatory filings, analytical methods, stability, drug substance and drug product specifications, and in-process controls.
Lead Product Quality Team activities to align product quality strategy, priorities, and deliverables across the product lifecycle.
Use the product quality risk register to identify, assess, and mitigate product quality risks using science- and risk-based approaches.
Monitor and review cross-functional process and product data, identify trends, and proactively address or escalate quality and compliance risks.
Lead development of control strategies, including in-process controls, 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 impacts of 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, by participating as a product expert.
Evaluate complex issues using science- and risk-based approaches and develop practical, patient-focused solutions that balance quality, regulatory expectations, and business needs.
Communicate complex quality and technical information to leadership, cross-functional teams, and regulatory agencies.
Act as delegate to the Commercial Product Quality Head, as needed.