QMS Supervisor - Biologics jobs in United States
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Astrix · 15 hours ago

QMS Supervisor - Biologics

positionMiddlesex County, NJ
timeFull-time
remoteOnsite
seniorityMid, Senior Level
money$90K/yr - $105K/yr
date6+ years exp

Astrix is a dynamic biopharmaceutical company seeking an experienced Quality Systems/QMS Supervisor to lead quality management initiatives within a biologics manufacturing environment. The role involves overseeing QMS activities, ensuring compliance with global regulatory standards, and driving continuous improvement initiatives.

ConsultingInformation Technology
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Kelsey Mease
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Responsibilities

Oversee all QMS activities including investigations, CAPA, documentation control, and report writing
Lead and manage PPQ and cleaning validation projects to support product and process integrity
Ensure ongoing compliance with FDA, EMA, ICH, and other global regulatory standards
Provide leadership and mentorship to quality team members; foster collaboration across manufacturing, validation, and regulatory teams
Support audits, inspections, and regulatory reviews, ensuring readiness and robust documentation
Drive continuous improvement initiatives, strengthening the QMS and aligning with industry best practices

Qualification

QMS leadershipBiologics manufacturingGMP complianceInvestigation report writingCAPA managementPPQCleaning validationContinuous improvementDocumentation managementTeam leadershipCollaboration skills

Required

Bachelor's degree in Life Sciences or a related field
6+ years of biologics manufacturing experience, with at least 3 years focused on QMS leadership
In-depth knowledge of upstream and downstream biologics processes
Demonstrated experience in investigation report writing, CAPA, and documentation management
Strong background in PPQ, cleaning validation, and global GMP/regulatory compliance

Company

Astrix

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Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.
dateFounded in 1995
location
Red Bank, New Jersey, USA
people-size1001-5000 employees
web-link
http://astrixinc.com

H1B Sponsorship

Astrix 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 (10)
2024 (9)
2023 (10)
2022 (16)
2021 (11)

Funding

Current Stage
Late Stage

Leadership Team

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Dale Curtis
Chief Executive Officer
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Reid E. Simpson
Chief Financial Officer
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Recent News

PRWeb
Astrix Welcomes Industry Veteran Steve Duryee as Chief Operating Officer
2025-09-20
Company data provided by crunchbase