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
Quality Systems Lead in chicago at Unknown Company
This position is listed as full time and onsite.