Director, Product Quality Lead (PQL), Small Molecule Global Quality
Job Location:
Foster, CA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads 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 were 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 theserve as a product expert providingtechnical scientificand strategicexpertise and leadership to Product CMC (Chemistry Manufacturing and Controls)/Product Development and Manufacturing(PDM)TeamandProduct QualityTeam (PQT)during clinical development throughcommercializationacting as the single point ofcontact forproduct quality.The PQLwill define the product Quality and Compliance strategy for theassignedproductsbyleveragingtheirunderstanding of product development tofacilitate theexecution of the strategies that enable the efficient commercialization ofproducts. ThePQL is responsibleforend-to-endProduct 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 isresponsibleforevaluating and driving overall ProductHealth byproactivelyidentifyingand mitigating productrisksandissues ensuring continuous improvementthroughoutthe product lifecycle. The role supports cross-functionalProduct Quality initiatives to strengthen complianceenhanceproductqualityandenablerobustlifecycle 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 scientificknowledgerelated toproduct developmenttechnology transfers global regulatory filing strategies analytical methods stabilitydrug substance and drugproduct specificationsand In-Process Controls (IPCs)
Lead Product Quality Team (PQT) activities toalign onproductquality 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 toidentifytrends and ensure quality and compliance risks are proactively addressed and escalated as needed.
lead thedevelopmentofcontrolstrategies includingin-processcontrolstartingmaterial drug substance and drug productspecifications stability strategy and comparability approaches.
Reviewandapproveregulatoryfilings and support responses to health authority questions.
Providecross-functional guidance to alignproductquality strategy acrossdevelopmentmanufacturinganalytical andregulatory stakeholders.
Assess product quality impact for changes deviations and events and ensureappropriateimplementationplans aredeveloped.
Support drug substance and drug product technology transfer and new product launches.
Ensure inspection readiness including PAI/PLI preparationthroughparticipation as aproductexpert
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 QualityHead as needed
Knowledge Experience and Skills:
In-depthunderstanding ofcGMP principlesandapplicable regulatory guidelines and directives (e.g.ICH EPJPUSP 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 toidentify assess and communicate product quality risks and driveappropriate mitigationstrategies.
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 tooperateindependently manage multiple priorities and make sound decisions in a fast-paced environment.
Basic Qualifications:
PriorQualityleadership and technicalmanagementexperiencein developmentand/orcommercialprograms.
12years of relevant experience and aBachelorsdegree in scienceor related fields;or10 years of relevantexperience and an advanced science degree such as MS Pharm DPhDDemonstrated experience and knowledge inquality ina highly regulated manufacturing environment.
Direct experience withregulatoryhealth authority submissions (e.g.IND NDA BLA MAA) and/or inspections.
Broad experience across several includinganalytical productcharacterizationlprocess 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 interpersonalverbaland written communication skillsincluding facilitation and presentation skillsare 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 anddemonstrateability to organizeprioritizeand 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 ofBLA/MAAs INDs/IMPDs supplements/variations or similar regulatory documentation highly desired.
Experience supporting non-conformance investigations authoringreviewingand defending critical product impacting non-conformances
Ability to work and navigate within an evolving
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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 disabilitygenetic 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 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 for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
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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. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Director
About Company
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensu ... View more
