Gilead Sciences

Director, Product Quality Lead (PQL), Global Quality

United States - California - Foster City · Director

Sponsorship not specified$210k-$272kDetected 14 days ago

Product ManagementCustomer SupportGMPLeadershipCommunicationCollaborationProblem Solving

About the role

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 evaluating and driving overall Product Health by proa c tively identifying and mitigating product risks and issues, ensuring continuous improvement throughout 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.

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
We promote and support individual differences and diversity of thoughts and opinion.
Support drug substance and drug product technology transfer and new product launches.
Apply science- and risk-based evaluation to complex issues and develop practical, patient-focused solutions that balance quality, regulatory expectations, and business needs.
Join Gilead and help create possible, together.

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 e xperience and knowledge in quality in a highly regulated manufacturing environment.
Broad experience across several including analytical product characterizationl, process validation, drug development experience, packaging/labeling and understanding of Parenteral, Oral Solid Dosage, and Biologics.

Excellent interpersonal, verbal and written communication skills, including facilitation and presentation skills, are essential in this collaborative work environment.
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

In-depth understanding of cGMP principles and applicable regulatory guidelines and directives ( e.g., ICH, EP, JP,USP, 21 CF R)
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.
Experience supporting inspections (e.g., PAI/PLI) and interacting with regulatory agencies.
Communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences.

$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.

include company-sponsored medical, dental, vision, and life insurance plans*.
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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.

At Gilead, we're creating a healthier world for all people.
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.
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.

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.

This listing is sourced directly from Gilead Sciences's careers page and normalized into a canonical job model.