Sr. Specialist - Trainer, Quality Assurance

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

Join us as a Senior Specialist I Trainer, Quality Assurance, Quality Systems!

Join Abeona Therapeutics as a Senior Specialist I Trainer, Quality Assurance, Quality Systems in our Quality Assurance - Quality Systems department and be a part of a mission-driven organization devoted to putting patients first. In this role, you will play a crucial part in ensuring that our cutting-edge health care solutions meet the highest quality standards and that our teams are prepared to perform. Collaborate with talented individuals dedicated to transforming lives through innovative therapies.

Abeona Therapeutics Inc.: Who We Are

Our Values: Patient First | Innovation | Integrity | Determination | Trust

At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.

Your day-to-day as a Senior Specialist I Trainer, Quality Assurance, Quality Systems

The Senior Specialist I Trainer, Quality Assurance performs routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position supports the maintenance and continuous improvement of quality systems in support of cGMP operations, including corrective and preventive actions (CAPA), quality events management (e.g., nonconformances and deviations), change control, training, document management, and regulatory compliance. The Senior Specialist will serve 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.

Schedule

The general working hours for this role are Monday to Friday (some late or weekend work may be required) from 9:00 a.m. to 5:00 p.m. (start and end times may vary) (with some late night or weekend work on occasion). Work from home flexibility one day per week (with approval).

Does this sound like you?

To thrive as a Senior Specialist I Trainer, Quality Assurance, Quality Systems, the right combination of experience, education, skills, and attitude is essential.

Picture someone who loves turning compliance into confidence. You're a quality-minded trainer with a life sciences or technical degree, 3-5+ years of biotech or pharma experience, and a strong command of FDA regulations and data integrity. You build clear, effective GMP training, keep every record inspection-ready, and stay organized in a fast-paced environment. As a natural communicator and collaborator, you partner with SMEs and leaders to make sure every teammate is qualified, compliant, and ready to put patients first.

Essential Responsibilities and Duties

• Serve as the primary owner for one or more Quality Systems programs, with responsibility for leading the site Training Program and potentially supporting Document Control, CAPA, Deviations/Investigations, Change Control, or other Quality System functions
• Lead and administer the site GMP Training Program, ensuring 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 Training Management System, including assignment of training, creation of training plans, and other administration activities, as applicable.
• Monitor training compliance metrics, identify gaps and overdue training requirements, and partner with department leaders to ensure timely completion.
• Evaluate training effectiveness through assessments, observations, performance metrics, and feedback mechanisms, implementing 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 (SMEs) to develop, review, and update training content related to GMP operations, quality systems, and regulatory requirements.

Required Qualifications

The background, knowledge, and skills required to be successful in the role are:

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field (Degrees in Education, Organizational Development or related, plus industry experience are also acceptable)
• 3-5+ years of experience within the biotechnology or pharmaceutical industry.
• Experience administering GMP training programs, Learning Management Systems (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.

Compensation and Benefits

• The anticipated base salary range for this position is $70,000 - $84,000 (Actual compensation will depend on experience, qualifications, and work location)
• Annual discretionary bonus
• Equity opportunities
• Robust health coverage options
• FSA/HSA options
• Company-paid basic dental and vision plans
• Lifestyle spending account (wellness reimbursements)
• Up to 160 hours of paid time off accrual per calendar year (prorated based on date of hire)

Physical Demands

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. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional work in laboratory, cleanroom, or manufacturing environments may be required. Occasional lifting up to 25 pounds is required. May require wearing appropriate personal protective equipment (PPE) when entering GMP or lab areas. Occasional walking, standing, or climbing stairs within office or facility settings. Must be able to travel between company sites or to vendor locations, if needed.

Important Notes for Candidates:

Visa Sponsorship Not Currently Available

• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
• This is a career-path role that is not suitable for someone whose work authorization is temporary and based on optional practical training (OPT).
• Current or future H-1B sponsorship is not available for this role.

Additional Notes to Applicants:

• Due to the volume of applications received, we are unable to respond to every applicant. Only candidates whose qualifications most closely match the requirements of the position and who successfully complete the initial stages of the selection process will be contacted.
• All applications will be reviewed in accordance with applicable federal, state, and local employment laws.

EEOC Disclaimer

We're committed to building a workplace where everyone feels welcome. We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, gender identity or expression, sexual orientation, age, disability, veteran status, or any other protected status.