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QA Supervisor

QA Supervisor

LongeveronMiami, FL, US
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Job Description

Job Description

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
  • This role is not available for sponsorship including I-983 participation

    • What we offer

    At Longeveron, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including :

  • Medical, dental and vision benefits (employee premiums covered  at100% & 90% coverage for spouse / family)
  • 401(k) plan with company match
  • Generous paid time off plan and company holidays
  • 2 paid company shutdowns (winter and summer)
  • Employee assistance program
  • Life and supplemental AD&D insurance

    • Physical and Environmental Requirements

    This role works in a clinical manufacturing lab and involves routine use of manufacturing equipment following GMP protocols and may include exposure to cryogenic materials and biological agents. This role involves working in a clean room environment that requires the ability to follow gowning procedures and adherence to strict hygiene standards, working with a team of operators, receiving comprehensive training and support from the operations team.

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Ability to remain standing or stationary for extended periods within a cleanroom or lab setting
  • Frequent use of computers and other office and lab productivity tools
  • May need to lift or carry items up to 30 pounds
  • Must be able to wear cleanroom gowning and PPE for extended periods and must pass cleanroom gowning certification within 90 days of start date
  • Adhere to internal PPE requirements when working in controlled areas

    • We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Longeveron Inc will not pay fees to any third-party agency or firm associated with unsolicited resumes.

    Longeveron is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Longeveron, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

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