Quality Assurance Supervisor

About Us Longeveron Inc, a publicly traded (NASDAQ :

• LGVN), clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, with our headquarters located in Miami, FL.
• Our lead investigational product is laromestrocel, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors.
• We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult rare diseases and conditions associated with aging.
• About the Job We are seeking an experienced and knowledgeable QA Supervisor to join our cGMP Quality Assurance team.
• Reporting to the VP of Quality, the QA Supervisor will lead and mentor the QA team while providing quality oversight of Manufacturing and Quality Control activities.
• This role ensures compliance with applicable U.S. regulations, guidance, industry standards, and internal procedures for both early- and late-phase clinical and commercial manufacturing of biological drug substances and products, with a focus on phase-appropriate controls.
• The QA Supervisor will support continuous improvement across manufacturing processes, analytical testing, and computerized systems, and will play a key role in developing and maintaining robust systems for qualification and validation activities.
• This role is based onsite at our Miami location and typically requires in-office presence five days a week.
• Relocation assistance is not available.

What You’ll Do Manage QA oversight for manufacturing lot release, including investigations, change controls, and inspections Establish, implement, and maintain GMP practices to measure and control quality in the production process Write, revise, and review Standard Operating Procedures (SOPs) and other GMP documentation Serve as the QA liaison with Technical Operations to support company goals, continuous improvement initiatives, and act as a general resource Support the program for quarantine and release of GMP cleanrooms following environmental disruptions, ensuring facilities, utilities, and equipment are acceptable for GMP manufacturing Provide QA support to Technical Operations, including review and approval of deviations and investigations, ensuring containment, risk mitigation, thorough impact assessment, and root cause identification Ensure implementation of appropriate Corrective and Preventive Actions (CAPAs) using tools such as Cause and Effect Diagrams and Five Whys Continually evaluate systems and procedures to improve efficiency while ensuring regulatory compliance Serve as a change agent for continuous improvement within the scope of work Lead, mentor, and develop QA team members to foster engagement, accountability, and high performance in alignment with organizational goals  What you'll need Bachelor’s degree in Life Sciences discipline is required, Master’s degree preferred Minimum of 5 years QA experience working within a cGMP controlled environment - Manufacturing experience is preferred Minimum of 1 year of experience in a supervisor / people leader role required Demonstrates knowledge and application of GMP principles in cell therapy manufacturing Strong interpersonal, written, and verbal communication skills; thrives in fast-paced, collaborative environments Skilled in problem-solving, root cause analysis, and making sound decisions with limited or complex data Demonstrates sound judgment in selecting appropriate methods and approaches to achieve results Proven people leader with the ability to effectively manage, develop, and motivate high-performing teams Able to work flexible working hours, including evenings and weekends as needed (included in base salary) Able to travel to support external manufacturing and testing activities