Clinical Quality Assurance Manager

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Full-time Regular Lake Forest, IL, US

3 days ago Requisition

CLINICAL QUALITY ASSURANCE MANAGER

If you are interested in joining an entrepreneurial team, focused on bringing life‑saving therapies to market for critical unmet medical needs, consider applying for a role at Cor Medix Therapeutics.

Cor Medix Therapeutics’s greatest asset is our people. We have a deeply experienced team and continue to bring on some of the brightest talent that can problem solve and execute with high‑precision. We are passionate about the work we do and how we do it. We believe in building highly engaged teams that exude integrity, open communication, and innovation. We believe in fostering each employee to reach their highest potential by offering an inclusive environment, opportunities to challenge yourself and grow, and a community of purpose.

We expect that everyone here brings their best selves to work and together, our singular efforts culminate into profound and meaningful breakthroughs.

Cor Medix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life‑threatening conditions and diseases. Cor Medix is commercializing Defen Cath® (taurolidine and heparin) for the prevention of catheter‑related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, Cor Medix is also commercializing a portfolio of anti‑infective products, including MINOCIN® (minocycline), REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL‑XL® (metoprolol succinate).

Cor Medix has ongoing clinical studies for Defen Cath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop Defen Cath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT.

Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit:  or

The Clinical Quality Assurance Manager is responsible for implementing, maintaining, and ensuring the effectiveness of the Good Clinical Practices (GCP) Quality processes and broader Quality Management System (QMS) elements to ensure high‑quality pharmaceutical products comply with global regulatory requirements. This includes oversight and continuous improvement of key QMS components such as document control, training management, audit and inspection readiness, deviation and CAPA management, risk management, vendor qualification, and quality governance processes.

The Clinical Quality Assurance Manager will serve as a strategic partner to the Clinical Operations, Technical Operations and Quality, and will be focused on developing Cor Medix’ GCP quality strategies, strengthening the Clinical QA Global function, and ensuring QMS integration across clinical operations and supporting functions.

• Lead the Clinical Quality function and ensure alignment with Melinta’s Quality Management System (QMS) and global GCP requirements
• Provide QA guidance to clinical and nonclinical teams throughout study planning and execution
• Develop, maintain, and implement GCP‑related SOPs, policies, and training programs
• Oversee vendor and CRO qualification, risk assessments, and ongoing compliance
• Manage the Clinical QA audit and inspection program, including internal, vendor, and investigator site audits
• Serve as QA representative during regulatory inspections and coordinate timely responses
• Monitor study conduct, protocol adherence, and data integrity across clinical programs
• Investigate significant noncompliance and implement…