Director, Product Quality Lead (PQL), Global Quality

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 Summary:

The Product Quality Lead (PQL) supports one or more assigned products/programs and serves as the

serve as a product expert provid

ing

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

commercializatio

n,

,

acting as the single point of

contact for

product quality. 

The PQL

will define the product Quality and Compliance strategy for the

assigned

product

s

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 document

ation

(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

proa

c

tively

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.

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 method

  s

  , 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

  , d

  rive 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

  d

  evelop

  ment

  of 

  controlstrategies, includingin-process

  control, 

  starting

  material, drug substance and drug product

  specifications, stability strategy, and comparability approaches. 

• R

  eview

  and

  approve 

  regulatoryfilings and support responses to health authority questions. 

• Provide

  cross-functional guidance to align

  product

  quality strategy across

  d

  evelopment,

  m

  anufacturing,

  a

  nalytical, and

  r

  egulatory 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 neede

  d

Knowledge, Experience and Skills: 

• In-depth

  understanding of

  cGMP principles

  and

  applicable regulatory guidelines and directives (

  e.g.

  , 

  ICH

  , EP,

  JP,USP

  , 21 CF

  R)

• 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

  commercialprograms

  .

• 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 e

  xperience and knowledge in

  quality  in

  a highly regulated manufacturing environment

  .

• D

  irect experience with

  regulatory

  health authorit

  y 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.

Preferred Qualifications / Skills:

• 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

The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex

, age, sexual orientation, physical or

mental

disability, genetic

information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact

ApplicantAccommodations@gilead.com

 for assistance.

For more information about equal employment opportunity protections, please view the 

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