Director, Product Quality Lead (PQL), Global Quality

Gilead Sciences•Foster City, CA

1d•$210,375 - $272,250

About The Position

The Product Quality Lead (PQL) supports one or more assigned products/programs and serves as the serve as a product expert providing technical, scientific and strategic expertise and leadership to Product CMC (Chemistry Manufacturing and Controls) / Product Development and Manufacturing (PDM) Team and Product Quality Team (PQT) during clinical development through commercialization,, acting as the single point of contact for product quality. The PQL will define the product Quality and Compliance strategy for the assigned products by leveraging their understanding of product development to facilitate the execution of the strategies that enable the efficient commercialization of products. The PQL is responsible for end-to-end Product Quality deliverables, including ownership, authoring, and review of GMP and regulatory documentation (including Product Quality sections of filings such as JOS), and management of product quality data such as comparability assessments, Annual Product Quality Reviews (APQRs), and product quality risk assessments. The PQL is responsible for evaluating and driving overall Product Health by proactively identifying and mitigating product risks and issues, ensuring continuous improvement throughout the product lifecycle. The role supports cross-functional Product Quality initiatives to strengthen compliance, enhance product quality, and enable robust lifecycle management. The PQL also serves as the primary Quality interface for alliance management and due diligence activities, ensuring alignment and effective collaboration with external partners.

Requirements

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.
Prior Quality leadership and technical management experience in development and/or commercial programs.
12+ years of relevant experience and a Bachelor’s degree in science or related fields; or 10+ years of relevant experience and an advanced science degree such as MS, , Pharm D, 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 including analytical product characterizationl, process validation, drug development experience, packaging/labeling and understanding of Parenteral, Oral Solid Dosage, and Biologics.

Nice To Haves

5+ years working in a regulated environment (either direct GMP or technical support)
Excellent interpersonal, verbal and written communication skills, including facilitation and presentation skills, are essential in this collaborative work environment.
Communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences.
Ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
Must be able to work on multiple projects simultaneously and demonstrate ability to organize, prioritize and manage time
Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
Experience with authoring or review of BLA/MAAs, INDs/IMPDs, supplements/variations or similar regulatory documentation, highly desired.
Experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
Ability to work and navigate within an evolving

Responsibilities

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