momentum staffing groupChicago, IL
Quality Systems Lead
Quality Systems Lead
Quality Systems Lead
momentum staffing groupChicago, IL
yesterday
Research and Development in Biotechnology (except Nanobiotechnology)Pharmaceutical Preparation ManufacturingBiological Product (except Diagnostic) Manufacturing
Apply for this role →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
Also on the board Same function, level within a rung
Level
Manager
Location
Chicago, IL
Occupation
Quality Control Systems Managers
Industry
Research and Development in Biotechnology (except Nanobiotechnology)
Posted
yesterday