About this opportunity
Momentum Staffing Group LLC lists this Quality Systems Lead opportunity in chicago, Illinois. Review the employer’s description below for duties, qualifications and application requirements.
Job description
About the Role
A Chicago-based preclinical biotech is seeking a Quality Lead to build its Quality Management System (QMS) from the ground up. This is a foundational hire, working closely with R&D and leadership to establish quality infrastructure as the company advances toward IND-enabling studies.
What You'll Do
Build and own the QMS: SOPs, document control, deviations/CAPA, change control
Establish quality oversight for preclinical studies
Partner with development teams and external partners to embed quality standards early
Support vendor qualification and audits
Serve as the company's quality SME, advising leadership on risk and regulatory readiness
What We're Looking For
5-10 years of Quality experience in drug development
Experience building or maturing a QMS, ideally at an early-stage biotech
Working knowledge of preclinical regulatory requirements
Comfortable as a hands-on IC in a small-company setting
Strong communicator across non-quality stakeholders
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Worksite address
chicago, IL, 60290, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.