Senior QA Trainer, Quality Systems — Flexible + Equity

Abeona Therapeutics Inc.; Cleveland (OH); On-site; USD 70,000 - 84,000; Full time

Benefits offered by this job

Annual discretionary bonus

Equity opportunities

Robust health coverage options

FSA/HSA options

Dental and vision plans

401(k) retirement plan

Paid time off 160 hours per year

Job summary

Abeona Therapeutics Inc. in Cleveland, OH, is seeking a Senior Specialist I Trainer, Quality Assurance, Quality Systems to lead the site GMP Training Program and drive training excellence across quality systems.

You will ensure regulatory compliance, maintain training records, and coordinate onboarding and retraining for GMP personnel. The role requires 3–5+ years in biotech/pharma with strong FDA/data integrity knowledge, excellent communication, and organizational skills, enabling you to

Qualifications

• Bachelor's degree in Life Sciences, CS, Engineering, or related field.
• 3–5+ years of experience in biotech or pharmaceutical industry.
• Experience administering GMP training programs, LMS, 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.
• Highly organized and able to manage multiple priorities in a fast-paced biotech environment.

Responsibilities

• Own one or more Quality Systems programs and lead the site Training Program.
• Lead and administer the site GMP Training Program, ensuring regulatory compliance.
• Develop, maintain, and improve training curricula, qualification programs, and learning materials for GMP personnel.
• Coordinate onboarding, GMP orientation, role-based qualifications, annual retraining, and ongoing learning initiatives; administer the Training Management System.
• Monitor training compliance metrics, identify gaps and overdue training, and partner with department leaders.
• Evaluate training effectiveness through assessments, observations, performance metrics, and feedback; drive improvements.
• Maintain employee training records and ensure training documentation is inspection-ready.
• Support and represent Training during internal audits, regulatory inspections, and customer audits.
• Partner with SMEs to develop and update training content related to GMP operations.

Skills

Biotech/pharma experience

GMP training programs

LMS experience

FDA regulations

Communication skills

Organization skills

Education

Bachelor's degree in Life Sciences / CS / Engineering

Job description

Abeona Therapeutics Inc. in Cleveland, OH, is seeking a Senior Specialist I Trainer, Quality Assurance, Quality Systems to lead the site GMP Training Program and drive training excellence across quality systems.

You will ensure regulatory compliance, maintain training records, and coordinate onboarding and retraining for GMP personnel. The role requires 3–5+ years in biotech/pharma with strong FDA/data integrity knowledge, excellent communication, and organizational skills, enabling you to