Senior Specialist, Quality Systems

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

Join us in making cure the new standard of care. 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.

Company Description

Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. Notably, Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first autologous cell-based gene therapy treating wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The company's cGMP manufacturing facility in Cleveland, Ohio, is dedicated to producing ZEVASKYN™. Abeona's portfolio includes adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with unmet medical needs, and their novel AAV capsids aim to improve treatment outcomes for various debilitating conditions.

Position Overview

The Senior Specialist I, Quality Assurance performs routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This early to mid-career position helps leads the maintenance of the quality systems in support of a cGMP Operations, corrective and preventative actions, quality events management (e.g., nonconformances, deviations, etc.), training, document management, change control, and ensuring procedural and regulatory compliance throughout the manufacturing process. The Senior Specialist I, Quality Assurance will report to the Supervisor, Quality Assurance or above. While there may be some flexibility for remote work, this position requires the candidate be available to work up to five days per week on site. Work outside of usual working hours may be required. Position is Day Shift with occasional weekends (as needed).

Essential Duties and Responsibilities

• Review non-conformances and ensure effective corrective/preventive actions (CAPA) are implemented in a timely manner.
• Write new standard operating procedures or revise existing documentation utilizing document management systems.
• Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
• Develop and present metric reporting and data analysis to help new processes or drive process improvement for quality systems.
• Perform training for new and existing team members, prepare training materials as necessary.
• Support site inspections and inspection readiness activities. Ensure the site is audit ready.
• Assists in internal audits of functional areas.
• Lead one of the following with minimal oversight: Document Control, CAPA, Deviations/Investigations, Change Controls, Training, or other key functions and cross train to support other functions.
• Work closely with functional groups to ensure processes and personnel remain in compliance with site procedures, regulatory and cGMP guidelines.
• Prioritize Quality Assurance workload as needed/priorities shift.
• Enhance skills via regular training and continuing education, including professional society membership/participation.
• Perform other duties as required.

Qualifications

• Minimum of a Bachelor's degree in related field and/or equivalent experience.
• Minimum of 5 years of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
• Working knowledge of quality systems and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
• Working knowledge of GCP, GDP, GLP and cGMP regulations and their relevant ISO counterparts and ICH Guidelines
• Thorough knowledge of aseptic manufacturing processes.
• Excellent organizational skills, attention to detail, and Good Documentation Practices.
• Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
• Ability to communicate and work independently with scientific and/or technical personnel.
• Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.

Preferred Qualifications

• Previous experience leading CCRB
• Previous experience leading a team to achieve clear results on a project

Additional Competencies

• Excellent organizational skills, attention to detail, and Good Documentation Practices.
• Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
• Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.
• Ability to thrive in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.

Benefits

Our values apply to how we view caring for each other as well. While the patient comes first, our employees are vital to making that happen, and so we strive to offer a competitive benefits package that includes:

• Medical insurance coverage (multiple options to meet our employees' and their families' needs)
• Dental and vision coverage
• 401k match plan
• Lifestyle spending account
• Compensation (annual): $74,000 - $92,000 (note: total annual compensation listed is based on annual salary and anticipated annual bonus)

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 accommodations 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 lifting up to 20 pounds is required.

This is a flexible work role. This position is eligible to work remotely on a periodic basis based on site needs. The position has flexibility in conducting some work activities remotely while also having work that requires him/her to be at the office on a regular basis. All days working remotely require manager approval.

Visa Sponsorship Not Currently Available

IMPORTANT: 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.