Apply on Employer Site

Melinta Therapeutics · 4 hours ago

Clinical Quality Assurance Manager

Parsippany, NJ

Full-time

Hybrid

Senior Level, Lead/Staff

10+ years exp

CorMedix 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 leading the Clinical Quality function and collaborating with various teams to drive continuous improvement.

BiotechnologyEmergency MedicineHealth CarePharmaceutical

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

Quality Management System (QMS)Clinical Practices (GCP)Clinical Quality ProgramsFDAICH standardsClinical research activitiesLeadership skillsCommunication skillsNegotiation skillsRelationship buildingTeamwork

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