Clinical Quality Assurance Manager
About The Position
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 CorMedix’ GCP quality strategies, strengthening the Clinical QA Global function, and ensuring QMS integration across clinical operations and supporting functions.
Requirements
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
101-250 employees
