Senior Quality Assurance Specialist, QMS Operations jobs in United States
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Evotec · 17 hours ago

Senior Quality Assurance Specialist, QMS Operations

positionRedmond
timeFull-time
remoteHybrid
seniorityMid, Senior Level
money$92K/yr - $126K/yr
date5+ years exp

Just-Evotec is a forward-thinking team on a mission to foster curiosity and innovation. They are seeking a Senior Quality Assurance Specialist to manage day-to-day QA responsibilities for GMP manufacturing and enhance quality assurance systems, collaborating with various teams to ensure compliance with regulations.

BiotechnologyHealth CarePharmaceuticalTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Review and assess all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements
Provide inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders
Develop, review, and deliver training regarding QMS process or system changes
Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records)
Monitor and review effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement
Alert senior management of significant quality, compliance, supply, and safety risks

Qualification

CGMP complianceQuality Management SystemsBiopharmaceutical experienceRisk assessmentTraining developmentCross-functional communicationAttention to detail

Required

Bachelor's degree in biological or engineering science
Minimum of 5 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment
Ability to collaborate and communicate cross-functionally
Proven attention to detail

Benefits

Discretionary annual bonus
Comprehensive benefits to include Medical, Dental and Vision
Short-term and long-term disability
Company paid basic life insurance
401k company match
Flexible work
Generous paid time off
Paid holiday
Wellness and transportation benefits

Company

Evotec

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Evotec is a pharmaceutical and life science company that provides drug discovery and gene therapy solutions.
dateFounded in 1993
location
Hamburg, Hamburg, DEU
people-size5001-10000 employees
web-link
http://evotec.com

H1B Sponsorship

Evotec 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 (5)
2023 (2)
2022 (2)
2021 (3)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$746.74M
Key Investors
Bill & Melinda Gates FoundationKorea Advanced Institute of Science and TechnologyOpen Philanthropy
2025-05-07Grant· $2.5M
2025-01-22Grant
2023-12-19Grant· $2.5M

Leadership Team

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Christian Wojczewski
CEO
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Claudia Karnbach
EVP, Global Head of Partnerships and Alliances
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Recent News

pharmaphorum
Amgen inks $840m takeover of UK's Dark Blue Therapeutics
2026-01-07
EuropaWire
Evotec Establishes Integrated Communications and Investor Relations Leadership Role
2026-01-04
PharmiWeb
Evotec Appoints Dr. Sarah Fakih as EVP, Head of Global Communications and Investor Relations
2026-01-03
Company data provided by crunchbase