Sr. Specialist - Trainer, Quality Assurance

Abeona Therapeutics • Cleveland, OH

6d • Hybrid

About The Position

The Senior Specialist I Trainer, Quality Assurance, Quality Systems performs routine activities associated with manufacturing cell and gene therapy products at Abeona Therapeutics Inc.’s Cleveland, Ohio site. The role supports the maintenance and continuous improvement of quality systems for cGMP operations, including CAPA, quality event management, change control, training, document management, and regulatory compliance.

The position serves as a key leader for the site GMP Training Program, overseeing training systems, curriculum development, compliance metrics, and training effectiveness to ensure personnel are qualified and compliant with regulatory and company requirements. The role may also support other Quality System functions, including Document Control, CAPA, Deviations/Investigations, and Change Control.

The general schedule is Monday through Friday, 9:00 a.m. to 5:00 p.m., with start and end times that may vary. Some late or weekend work may be required. Work-from-home flexibility is available one day per week with approval.

Requirements

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field; degrees in Education, Organizational Development, or a related field are also acceptable with industry experience.
• 3–5+ years of experience within the biotechnology or pharmaceutical industry.
• Experience administering GMP training programs, Learning Management Systems, or training compliance programs.
• Experience developing training curricula, qualification matrices, training effectiveness measures, and employee development programs.
• Strong working knowledge of FDA regulations and data integrity principles.
• Excellent written and verbal communication skills.
• Strong organizational skills and ability to manage multiple priorities in a fast-paced biotech environment.

Responsibilities

• Serve as the primary owner for one or more Quality Systems programs, leading the site Training Program and potentially supporting other Quality System functions.
• Lead and administer the site GMP Training Program in compliance with applicable regulatory requirements, company procedures, and training standards.
• Develop, maintain, and continuously improve training curricula, qualification programs, and learning materials for GMP personnel.
• Coordinate onboarding, GMP orientation, role-based qualifications, annual retraining, and ongoing learning initiatives across functional areas.
• Administer the Training Management System, including training assignments, training plans, and related administrative activities.
• Monitor training compliance metrics, identify gaps and overdue requirements, and partner with department leaders to support timely completion.
• Evaluate training effectiveness using assessments, observations, performance metrics, and feedback, and implement improvements as needed.
• Maintain employee training records and ensure training documentation is accurate, complete, and inspection-ready.
• Support and represent the Training function during internal audits, regulatory inspections, and customer audits.
• Partner with Subject Matter Experts to develop, review, and update training content related to GMP operations, quality systems, and regulatory requirements.

Benefits

• Annual discretionary bonus
• Equity opportunities
• Robust health coverage options
• FSA/HSA options
• Company-paid basic dental and vision plans
• Lifestyle spending account with wellness reimbursements
• 401(k) retirement plan
• Up to 160 hours of paid time off accrual per calendar year, prorated based on date of hire
• Work-from-home flexibility one day per week with approval

What This Job Offers

• Job Type: Full-time
• Career Level: Senior