Clinical Quality Assurance Manager at Melinta Therapeutics LLC

Lake Forest, Illinois, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Mar, 26

Salary

0.0

Posted On

30 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Quality Assurance, Good Clinical Practices, Quality Management System, Regulatory Compliance, Audit Management, Risk Management, Vendor Qualification, Corrective Actions, Data Integrity, Leadership, Communication, Negotiation, Teamwork, Clinical Research, Drug Development, Quality Assurance

Industry

Biotechnology Research

Description

CLINICAL QUALITY ASSURANCE MANAGER Why CorMedix Therapeutics? 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 CorMedix Therapeutics. The culture at CorMedix Therapeutics is patient-centered where we feel a sense of urgency to solve some of the most pressing issues in hospital-based healthcare. CorMedix 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. Company Description: CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (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, CorMedix 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). CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath 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: www.cormedix.com [javascript%3Avoid(0)] or www.melinta.com [javascript%3Avoid(0)]. Job Overview 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. Duties and 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 Qualifications * 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 Position Type Full Time - Exempt Position Travel * Preference for position to be in Lincolnshire IL or Parsippany NJ office location * Will consider flexible work options * As needed, approximately 10% CorMedix Therapeutics is an equal opportunity employer. The Company is committed to providing a safe, respectful, and professional work environment that is free from all forms of unlawful discrimination, harassment (including sexual harassment), and retaliation, and complies with all applicable laws prohibiting such conduct. CorMedix Therapeutics does not discriminate against any individual on the basis of race, religion, color, national origin, ancestry, sex, marital/civil union/domestic partner status, family or parental status, sexual orientation, age, disability, or any other status protected under applicable federal, state, or local law.

Responsibilities

The Clinical Quality Assurance Manager is responsible for implementing and maintaining Good Clinical Practices and ensuring compliance with global regulatory requirements. This includes oversight of key Quality Management System components and serving as a strategic partner to various operational teams.