Director, Product Quality Leader, Biologics

Gilead Sciences•Foster City, CA

1d•$210,375 - $272,250

About The Position

The Product Quality Lead (PQL) supports one or more assigned products or programs and serves as a product expert, providing technical, scientific, and strategic leadership to Product CMC/Product Development and Manufacturing teams and the Product Quality Team from clinical development through commercialization. The PQL is the single point of contact for product quality and defines product quality and compliance strategies that support efficient commercialization. The role owns end-to-end product quality deliverables, including authoring and reviewing GMP and regulatory documentation, managing product quality data such as comparability assessments and Annual Product Quality Reviews, and conducting product quality risk assessments. The PQL proactively identifies and mitigates product risks, supports continuous improvement throughout the product lifecycle, and contributes to cross-functional initiatives that strengthen compliance, product quality, and lifecycle management. The PQL is also the primary Quality interface for alliance management and due diligence activities with external partners.

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 within a highly regulated manufacturing environment.
Direct experience with regulatory health authority submissions, such as IND, NDA, BLA, or 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 products.
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.
Solid knowledge of drug substance and drug product development, manufacturing processes, and related 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 mitigation strategies.
Effective problem-solving skills, including developing practical, patient-focused solutions to complex quality issues.
Strong written and verbal communication skills and ability to convey complex quality and technical information to cross-functional teams, leadership, and regulatory agencies.
Ability to work independently, manage multiple priorities, and make sound decisions in a fast-paced environment.

Nice To Haves

At least 5 years of experience 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 organize, prioritize, and manage time while working on multiple projects simultaneously.
Comfort working in a fast-paced company environment with minimal direction and adjusting workload as priorities change.
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 in a matrix environment, drive alignment and decision-making, evaluate process and product quality data using scientifically sound, risk-based approaches, and develop patient-oriented strategies.
Execute and drive product strategies using expertise in product development, technology transfers, global regulatory filing strategies, 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 throughout the product lifecycle.
Use the product quality risk register to identify, assess, and mitigate product quality risks through science- and risk-based approaches.
Monitor and review cross-functional process and product data to identify trends, address quality and compliance risks proactively, and escalate issues as needed.
Lead development of control strategies, including in-process controls, starting-material, drug substance and drug product specifications, stability strategies, 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 transfers 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.
Serve as the primary Quality interface for alliance management and due diligence activities, ensuring alignment and collaboration with external partners.
Own, author, and review GMP and regulatory documentation, including Product Quality sections of filings such as JOS; manage comparability assessments, Annual Product Quality Reviews, and product quality risk assessments.
Drive overall product health by identifying and mitigating product risks and issues and supporting continuous improvement throughout the product lifecycle.