CorMedix Therapeutics · 9 hours ago
Clinical Quality Assurance Manager
Lake Forest, IL
Full-time
Hybrid
Senior Level, Lead/Staff
10+ years expCorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for critical unmet medical needs. The Clinical Quality Assurance Manager is responsible for implementing and maintaining Good Clinical Practices (GCP) Quality processes and ensuring compliance with global regulatory requirements while collaborating with various departments to enhance clinical development quality.
BiotechnologyHealth CareHealth Diagnostics
Responsibilities
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 effective corrective and preventive actions (CAPA)
Track and communicate clinical quality issues, trends, and key quality indicators
Collaborate with Clinical Operations, Regulatory Affairs, and other functions to drive continuous improvement in clinical development quality
Optimize the effectiveness of the Melinta drug development process through use of sound quality principles and measurement of key indicators such as inspection outcomes, protocol deviations, clinical investigators site audits, IRB/EC audits and vendor audits
Maintain accountabilities for relevant timelines and deliverables
Build mutually respectful and collaborative working relationships with Clinical operations, Regulatory Affairs, Quality Assurance, and other key functions within CorMedix
Qualification
Required
Bachelor's degree in a scientific related field
At least 10 years of experience managing Clinical Quality Programs involving drug development in the pharmaceutical/biologics industry, including hands-on experience with Quality Management System (QMS) implementation and oversight
Thorough knowledge of the drug development process and Quality/Regulatory interactions, including FDA and ICH standards and recommendations
Well versed in current international GxP regulatory requirements
Possess strong leadership skills, as well as communication and negotiation skills
Broad exposure and understanding of clinical research activities, including investigator responsibilities
Leadership competencies, including relationship building, influencing, fostering teamwork, knowledge of the business, sound judgment, and the ability to make difficult decisions
Experience managing partner relationships
Company
CorMedix Therapeutics
CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$96.47M2025-06-26Post Ipo Equity· $85M
2017-11-09Post Ipo Equity· $5M
2013-10-20Post Ipo Equity· $3M
Leadership Team
Joseph Todisco
Chief Executive Officer
Recent News
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