Quality Systems Lead

Momentum Staffing Group LLC; Chicago (IL); On-site; USD 120,000 - 170,000; Full time

Job summary

Momentum Staffing Group LLC is partnering with a Chicago-based preclinical biotech to hire a Quality Lead who will build the QMS from the ground up and establish quality infrastructure as the company advances toward IND-enabling studies.

You will own the QMS (SOPs, document control, deviations, CAPA, change control) and provide quality oversight for preclinical studies, while partnering with R&D and leadership to embed quality early in development.

Qualifications

• 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.
• Hands-on IC in a small-company setting.
• Strong communicator across non-quality stakeholders.

Responsibilities

• 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.

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