Director, Product Quality Leader, Biologics

Gilead Sciences•Foster City, CA

11d•$210,375 - $272,250

About The Position

The Product Quality Lead (PQL) supports one or more assigned products or programs and serves as the product quality expert, providing technical, scientific, and strategic leadership to Product CMC/Product Development and Manufacturing teams and Product Quality Teams from clinical development through commercialization. The PQL is the single point of contact for product quality and defines the quality and compliance strategy for assigned products, enabling efficient commercialization. The role owns end-to-end Product Quality deliverables, including authoring and reviewing GMP and regulatory documentation, managing product quality data and assessments, and proactively identifying and mitigating product risks throughout the product lifecycle. The PQL leads cross-functional quality initiatives and serves as the primary Quality interface for alliance management and due diligence activities with external partners. The position may act as delegate to the Commercial Product Quality Head as needed.

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 of quality in 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 associated quality considerations.
Experience working in cross-functional teams in a matrix environment and ability to influence decisions without direct authority.
Proven ability to lead or contribute to complex product or 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 ability to interpret complex product and process data and translate findings 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 for conveying 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 five years working in a regulated environment, either directly in GMP or in technical support.
Excellent interpersonal, verbal, and written communication skills, including facilitation and presentation skills.
Ability to communicate complex ideas succinctly and clearly to varied audiences.
Ability to influence others through persuasive interactions and garner support for novel solutions.
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 as priorities change.
Experience authoring or reviewing BLA/MAA, IND/IMPD, 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, driving alignment and decisions through scientifically sound, risk-based evaluation of process and product quality data.
Execute and drive product strategies using quality and scientific expertise in product development, technology transfers, global regulatory filing strategies, analytical methods, stability, specifications, and in-process controls.
Lead Product Quality Team activities and 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 using science- and risk-based approaches.
Monitor and review cross-functional process and product data, identify trends, and ensure quality and compliance risks are addressed and escalated as needed.
Lead development of control strategies, including in-process controls, starting material, drug substance and drug product specifications, stability strategies, and comparability approaches.
Own, author, review, and approve GMP and regulatory documentation, including product quality sections of filings; review and approve regulatory filings and support responses to health authority questions.
Manage product quality data and deliverables, including comparability assessments, Annual Product Quality Reviews, and product quality risk assessments.
Provide cross-functional guidance to align product quality strategies 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; support inspections and interactions with regulatory agencies.
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 to leadership, cross-functional teams, and regulatory agencies.
Serve as the primary Quality interface for alliance management and due diligence activities with external partners.
Act as delegate to the Commercial Product Quality Head, as needed.