Quality Systems Lead

Posted yesterday

momentum staffing groupChicago (IL)

Quality Control Systems Managers Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Manager

Apply

About the 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

Before you apply

Applying takes about a minute. These four things decide how fast it moves after that.

Your profile is current

It's what we read first. Occupations, seniority and locations matter more than a long history.

Two examples you can talk through

Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.

A number in mind

What you're on now and what would make you move. We negotiate better when we know both.

Your notice period

Employers plan around it, and it's the question that stalls offers most often.

Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.