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Director- QA Compliance

Director- QA Compliance

Gilead Sciences, Inc.Foster City, CA, US
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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 therap...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Test Technician, QA

Test Technician, QA

ICONMAFoster City, CA
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Our Client, an Av Manufacturing company, is looking for a Test Technician, QA for their Foster City, CA location.Conduct basic software operation tasks. Support missions through a wide variety of ro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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QA Training Specialist

QA Training Specialist

GileadSan Mateo, CA, US
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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 therapie...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Senior QA Engineer

Senior QA Engineer

RobinhoodMenlo Park, California, United States
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Join a leading fintech company that’s democratizing finance for all.Robinhood Markets was founded on a simple idea : that our financial markets should be accessible to all.With customers at the hear...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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QA Engineering Lead

QA Engineering Lead

Meta PlatformsMenlo Park, CA, US
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Meta builds technologies that help people connect, find communities, and grow businesses.When Facebook launched in 2004, it changed the way people connect. Apps like Messenger, Instagram and WhatsAp...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
QA Manager

QA Manager

Infospan IncFoster City, CA, California, USA
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Title : QA Manager- Location : On Site - Foster City, CA Experi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Test Technician, QA

Test Technician, QA

UrsusFoster City, CA
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Individual compensation is determined by skills, qualifications, experience, and location.Compensation details listed in this posting reflect the base hourly rate or annual salary only, unless othe...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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QA Release Engineer

QA Release Engineer

Vertex Sigma SoftwareFoster City, CA, US
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As a QA / Release Engineer, you will play a critical role in our software quality and delivery by driving process improvements to release our vehicle software regularly, reliably, and with high qua...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Senior QA Engineer, Automation

Senior QA Engineer, Automation

RobloxSan Mateo, CA, US
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For roles that are based at our headquarters in San Mateo, CA : The starting base pay for this position is as shown below. The actual base pay is dependent upon a variety of job-related factors such ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
QA Lead Coordinator.

QA Lead Coordinator.

Games Jobs DirectSan Mateo, United States
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Every day, tens of millions of people come to Roblox to explore, create, play, learn, and connect with friends in 3D immersive digital experiences- all created by our global community of developers...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Associate QA Analyst

Associate QA Analyst

IXLSan Mateo, CA
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IXL Learning, developer of personalized learning products used by millions of people globally, is seeking an Associate QA Analyst focused on UI and front end testing. The ideal candidate will have a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
QA Test Engineer

QA Test Engineer

Aechelon TechnologySouth San Francisco, California, United States
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D simulator content, including Geospecific visual / sensor databases and realistic 3D models.We seek people who share our passion for real-time computer graphics and commitment to our mission of help...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Senior Software QA Engineer

Senior Software QA Engineer

Culture BiosciencesSouth San Francisco, California, United States
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Culture’s mission is to simplify and accelerate bioprocess development to help our customers bring biopharmaceutical products to market faster. Focusing on upstream cell culture process development,...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
QA Training Specialist

QA Training Specialist

Gilead SciencesFoster City, California, United States
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Manages the development and implementation of learning programs to meet compliance goals, development needs, and operational excellence initiatives. Supports the coordination of training sessions in...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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QA Specialist, Vendor ComplianceBurlingame, California

QA Specialist, Vendor ComplianceBurlingame, California

OLIPOPBurlingame, CA, US
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QA Specialist, Vendor Compliance.At OLIPOP, we're on a mission to positively impact consumer health at scale.And we're doing it through something simple : soda. But not just any soda, a new kind of s...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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QA Testing Engineer

QA Testing Engineer

SamprasoftSan Bruno, CA, US
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Staff / Senior Mobile Qe Automation Engineer.Super critical req •mandatory requirements •1.serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Salesforce QA Tester

Salesforce QA Tester

StaffingSan Mateo, CA, US
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Bachelor's degree in Computer Science or related field of study.Quality Assurance experience with 4 years of exclusive SFDC QA experience. Jira, Selenium and other tools.Should be a certified Salesf...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Netflix QA Tester

Netflix QA Tester

TradeJobsWorkforce94128 South San Francisco, CA, US
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Help us succeed as our next Netflix QA Tester to perform responsibilities as a QA Tester.Stay adaptable to changing priorities and business needs. Stay adaptable to changing priorities and business ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
QA Lead

QA Lead

Propel LondonSAN MATEO
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As a QA automation Tech Lead you will provide thought leadership to the business's already well-established Automation Engineering team. You will provide expertise, support and leadership to a numbe...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Senior Engineering Manager (Platform + DevEx + QA)

Senior Engineering Manager (Platform + DevEx + QA)

KaavSan Mateo, CA, US
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Senior Engineering Manager (Platform + Devex + Qa).Location : Hybrid, Bay Area (San Mateo, CA 3x / week) Benefits include : health benefits, 401k, commuter benefits.serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Director- QA Compliance

Director- QA Compliance

Gilead Sciences, Inc.Foster City, CA, US
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Job Description

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 fulfill their aspirations. Join Gilead and help create possible, together.

Job Description

The Director- QA Compliance, will report to the Executive Director of Supplier Management and Auditing. This key position will be the acting Global Process Owner for External Audits and conduct GMP audits of Gilead's global suppliers with a primary focus on external biologics manufacturing, contract packaging, and contract testing labs. This position will lead audits to support the effectiveness of the global audit program and will work closely with cross-functional partners and internal stakeholders.

  • Lead the development, implementation, and maintenance of procedures and templates to assist in the evaluation of and in improvement of the auditing process.
  • Develop strategy for cross training and maintenance of auditor and SME qualifications.
  • Assist in overall scheduling and productivity / capacity modeling for audit team.
  • Identify compliance risks and escalate issues to appropriate levels of management for resolution.
  • Promote awareness across the biologics commercial and clinical manufacturing platform(s) of current regulatory agency requirements and trends and develop and report on the trends identified to better focus the scope of audits.
  • Align, strategize and collaborate with the Global Supplier Quality function within Gilead.
  • Enhance Global Third party Quality Oversight program and Qualification Process by leading initiatives to maintain compliance to global regulations and standards.
  • Represent the Quality function by developing the program and supporting the selection process for new / preferred suppliers.
  • Act as liaison between global supplier quality and Gilead's production facilities.
  • Conduct global vendor audits for contract manufacturing of Gilead Biologics.
  • Support and / or conduct audits of providers of raw materials, product contact consumables, contract manufacturing or testing, software, warehouse / distribution in support of Gilead's clinical and commercial oral and parenteral dosage formulations and associated medical devices as assigned.
  • Manage all aspects of the audit lifecycle including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA / PA, and closing.
  • Drive consistency with audit report observation writing, classification, status, and overall risk.
  • Conduct due diligence assessments as part of global expansion as required.
  • Identify and drive biologics audit program improvements and meet all required metrics and assigned goals.
  • Ensure CA / PA to address compliance concerns identified during audits are commensurate with current biologics industry practices and benchmarks.
  • Ensure that the audit agenda is risk-based and has the appropriate internal and / or external subject matter experts as part of the audit team.
  • Work directly with Gilead cross-functional departments to gather key information and feedback prior to conducting vendor audits in order to ensure effectiveness.

Travel is required up to 50%

This will be an on-site role, and can be located in Foster City, CA OR Parsippany, NJ

Essential Functions :

  • Supports Compliance management in maintaining the company's Compliance program.
  • Manages the day-to-day activities of one or more individual contributors, including task assignment and prioritization, monitoring task performance, and conducting performance reviews.
  • Ensures awareness of biologics compliance requirements across impacted functional areas.
  • Establishes excellent working relationships with compliance / quality groups.
  • Responsible for maintaining current knowledge of applicable compliance requirements through attendance at industry and regulatory agency sponsored meetings and seminars and individual self-study including periodic review of all relevant regulations, guidance documents, and requirements.
  • Responsible for providing guidance on interpretation and application of existing and new requirements. Provide guidance to assigned departments and management when specific compliance issues arise.
  • Assists in evaluation and implementation of standard operating procedures and systems needed to comply with requirements.
  • Leads various types of audits or projects or supervises contractors. Audits may include internal systems audits, external vendor audits, or document reviews.
  • Assists in regulatory agency inspections. Assists in coordination of responses to any regulatory agency findings.
  • Basic Qualifications :

  • 10+ years of relevant experience in the pharmaceutical industry and a BS or BA in a relevant field of study.
  • 8+ years of relevant experience and a MS in a relevant field of study.
  • Extensive background in Biologics Operations (e.g. Manufacturing, Quality Control, Quality Assurance).
  • Demonstrates excellent verbal, written, and interpersonal skills.
  • Demonstrates a thorough knowledge of compliance requirements, and an understanding of current global and regional trends in compliance.
  • Knowledge of domestic and international regulations including 21 CFR Parts 11, 203, 205. 210, 211, 600, 610, 820; EudraLex Volume 4 and applicable annexes; and Health Canada R.S.C., 1985, F-27, Section 30; as well as ICH, ISO, PIC / S and USP / NF, EP, and JP compendial standards and principles as applicable.
  • Skilled auditor with 10 years of experience and ability to perform investigative audits.
  • Is capable of taking a leadership role in updating and preparing the company for changes in regulations.
  • Is capable of leading a small team in development of systems and procedures and implementation.
  • Is well recognized as a knowledgeable resource for QA compliance advice in other departments.
  • Capable of effectively managing a small team of experienced subject matter experts in execution of audits.
  • 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

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