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