Senior QA Trainer - Quality Systems & Compliance

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

Benefits offered by this job

Annual discretionary bonus

Equity opportunities

Health coverage options

FSA/HSA options

Dental and vision plans

Wellness spending account

Paid time off (PTO)

Job summary

Abeona Therapeutics in Cleveland, OH is seeking a Senior Specialist I Trainer in Quality Assurance and Quality Systems to lead the site training program, maintain quality systems, and ensure regulatory compliance for cGMP operations.

You will develop curricula, manage training records, collaborate with SMEs and leaders, and drive training effectiveness while ensuring staff are qualified and prepared to put patients first.

Qualifications

• Bachelor's degree in Life Sciences or related field; Education/Organizational Development acceptable with industry experience.
• 3–5+ years in biotech/pharma with GMP training program experience.
• Experience in building training curricula, matrices, and effectiveness measures.
• Strong knowledge of FDA regulations and data integrity.
• Excellent written and verbal communication; highly organized with multiple priorities.

Responsibilities

• Serve as owner for Quality Systems programs and lead the site Training Program.
• Administer GMP Training Program aligning with regulatory requirements and procedures.
• Develop and maintain training curricula, qualification programs, and learning materials.
• Coordinate onboarding, GMP orientation, and annual retraining across functions.
• Monitor training compliance metrics and address gaps with leadership.
• Evaluate training effectiveness with assessments and feedback for continuous improvements.
• Maintain training records and ensure inspection-ready documentation.
• Support internal audits, regulatory inspections, and customer audits.
• Partner with SMEs to update training content on GMP operations and regulatory needs.

Skills

Life Sciences degree

GMP training

Curriculum development

FDA regulations

Training coordination

Communication skills

Organizational skills

Education

Bachelor's degree

Tools

LMS

Job description

Abeona Therapeutics in Cleveland, OH is seeking a Senior Specialist I Trainer in Quality Assurance and Quality Systems to lead the site training program, maintain quality systems, and ensure regulatory compliance for cGMP operations.

You will develop curricula, manage training records, collaborate with SMEs and leaders, and drive training effectiveness while ensuring staff are qualified and prepared to put patients first.