Quality Assurance Manager

(ID: 2025-0641)

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Axle is seeking a Quality Assurance (QA) Manager to join our Program Coordination Team in support of the National Institutes of Health (NIH) initiative to advance standardized organoid model development.

Benefits We Offer:

• 100% Medical, Dental & Vision Coverage for Employees
• Paid Time Off and Paid Holidays
• 401K match up to 5%
• Educational Benefits for Career Growth
• Employee Referral Bonus
• Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN)

Overview:

In this role, you will serve as the QA Manager, overseeing the quality systems and compliance operations of our state-of-the-art Organoid Research and Development Laboratory. The ideal candidate will bring extensive experience in quality management within regulated laboratory or biotechnology environments, with expertise in organoid or advanced cell culture systems, GMP/GLP practices, and a demonstrated commitment to continuous quality improvement.

This role is critical to ensuring that our organoid research and production meet the highest standards of scientific rigor, safety, and regulatory compliance as we transition toward preclinical and clinical applications. Familiarity with the FDA regulatory process for new drug development will be highly valued, as this knowledge will support the lab’s alignment with future translational and clinical requirements.

Responsibilities:

• Develop, implement, and maintain a comprehensive Quality Management System (QMS) tailored to organoid research and production.
• Ensure compliance with GMP, GLP, ISO 9001, and ISO 13485 standards.
• Manage controlled documentation, including SOPs, batch records, quality manuals, and training records.
• Lead internal audits, support regulatory inspections, and maintain audit readiness across all functions.
• Conduct risk assessments, manage Corrective and Preventive Action (CAPA) programs, and oversee quality improvement initiatives.
• Collaborate with scientists and operations teams to embed quality checkpoints into organoid workflows.
• Oversee the qualification of raw materials, reagents, and equipment, ensuring traceability and compliance.
• Develop and deliver training programs on quality practices, data integrity, and compliance requirements.
• Monitor documentation accuracy and data integrity to support reproducibility and regulatory compliance.
• Champion continuous improvement initiatives to enhance efficiency, reproducibility, and scientific excellence in organoid research.

Required Qualifications

• Ph.D. or MS in biology, biotechnology, Quality Management or a related field.
• At least 10 years of experience in Quality Assurance within a biotech, stem cell, or organoid laboratory environment.
• Strong working knowledge of GMP, GLP, and ISO 13485 standards.
• Proven track record of implementing and maintaining quality systems, including managing audits and inspections.
• Hands-on familiarity with organoid culture techniques and laboratory best practices.
• Demonstrated ability to collaborate across multidisciplinary teams to support scientific and regulatory excellence.

Preferred Qualifications

• Experience with electronic Quality Management Systems (eQMS) and Laboratory Information Management Systems (LIMS).
• Professional certifications such as Certified Quality Auditor (CQA) or ISO Internal Auditor.
• Familiarity with regulatory pathways for cell and gene therapies.
• Knowledge of the FDA regulatory process for new drug development, including preclinical requirements and investigational new drug (IND) applications.

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact: [email protected]

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location.

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