QA Senior Specialist - External Quality, Strategy, Processes and Metrics jobs in United States
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Gilead Sciences · 9 hours ago

QA Senior Specialist - External Quality, Strategy, Processes and Metrics

positionSan Francisco Bay Area
timeFull-time
remoteOnsite
senioritySenior Level
money$136K/yr - $176K/yr
date7+ years exp

Gilead Sciences is committed to creating a healthier world for all people, tackling major health challenges through innovative therapies. The Senior QA Specialist will maintain product specifications and ensure compliance with GMP systems, while managing specifications and change controls to facilitate product release and regulatory submissions.

BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Maintain commercial product specifications current in all GMP systems
Manage SAP workflow to ensure compliance to product dossiers and enable timely release of products
Lifecycle management of specification include revisions based on feedback from health authorities during post approval changes and submission of a commercial products to additional countries, or from continuous process verification where a change to approved specification is warranted
Manage change control record in GVault pertaining to specification revision
Participate in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met
Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
Participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products
Assist or lead compliance audits as required
Interface with regulatory agencies as required
Interface with internal sites and contract manufacturers to address inquiries from health authorities during product submission and post approval changes

Qualification

GMP experienceSAP proficiencyQuality Assurance principlesRisk Management toolsTechnical writingAnalytical skillsMicrosoft OfficeSix SigmaInterpersonal skillsCommunication skills

Required

7+ years of relevant experience in a GMP environment related field and a BS or BA
5+ years of relevant experience and a MS
Knowledge with specification setting and experience with assisting the response to health authority inquiries related to specifications are beneficial
Proficient in application of QA principles, concepts, industry practices, and standards
Demonstrates ability to effectively manage multiple projects/priorities
Has proven analytical and conceptual skills
Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
Demonstrates excellent verbal communication, technical writing and interpersonal skills
Demonstrates working knowledge and good proficiency in Microsoft Office applications

Preferred

Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products
May assist or lead compliance audits as required
May interface with regulatory agencies as required
Interfaces with internal sites and contract manufacturers to address inquiries from health authorities during product submission and post approval changes
Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial
Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial
Knowledge with IND/NDA/BLA submission process is desired

Benefits

Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Company

Gilead Sciences

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Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
dateFounded in 1987
location
Foster City, California, USA
people-size10001+ employees
web-link
http://www.gilead.com

H1B Sponsorship

Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (221)
2024 (246)
2023 (226)
2022 (208)
2021 (235)
2020 (187)

Funding

Current Stage
Public Company
Total Funding
$4.41B
Key Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B

Leadership Team

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Keeley Wettan
Senior Vice President, Legal
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Patrick Loerch
Senior Vice President, Clinical Data Science
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