Associate Manager, Quality Assurance, Quality Operations

Join us as an Associate Manager, Quality Assurance, Quality Operations!

Join Abeona Therapeutics as an Associate Manager, Quality Assurance, Quality Operations 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. Collaborate with talented individuals dedicated to transforming lives through innovative therapies.

Work on site four days per week, Sunday to Wednesday (10-hour shifts), from 8:00 AM - 6:00 PM and contribute to impactful products that change peoples' lives. With a competitive salary of $85,000 - $90,000 per year (this range includes base salary and anticipated annual bonus), this position not only offers financial rewards, but also the opportunity to build your career in a supportive, collaborative, and values-focused environment.

You will have options to participate in a comprehensive benefits program that includes options for Medical insurance to meet various individual/family needs, company covered basic Dental and Vision insurance (with additional coverage options), HSA and FSA options, a Lifestyle Spending Account, 401k options (with a company match program), and up to 160 hours of Paid Time Off per calendar year.

Oh, and snacks! We have healthy snacks and beverages, as well as a few good, old-fashioned sweets, so that you can keep those energy levels up throughout the day.

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.

As a Associate Manager, Quality Assurance, Quality Operations at Abeona Therapeutics, your day-to-day activities will focus on overseeing routine activities associated with the manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position oversees the maintenance of the quality systems in support of a cGMP Operation for production processes relating to batch record review and release from start to end of manufacturing activities.

This includes in-process sampling / testing, primary and secondary packaging, label control, and document management ensuring procedural and regulatory compliance throughout the manufacturing process. The Associate Manager, Quality Assurance will report to the Manager, Quality Assurance or above.

Your expertise will directly impact the quality and reliability of our therapeutic solutions, all while upholding our commitment to putting patients first. This position enables you to contribute meaningfully to the advancement of gene-based therapy solutions in a compliance-focused environment.

The usual working hours for this role are Sunday to Wednesday (10-hour shifts) from 8:00 AM - 6:00 PM (with some late night or weekend work on occasion).

To thrive as an Associate Manager, Quality Assurance, Quality Operations, the right combination of experience, education, skills, and attitude is essential.

Having a "quality mindset" that has been fine-tuned through at least five years of practical application in a quality role working in manufacturing (pharmaceutical, biotech, or biologics) in a cGMP regulated environment is key to being successful in this role. Attention to detail and the ability to oversee multiple team members' work to ensure compliance and accuracy, while also ensuring that communication between the quality teams, manufacturing, and other departments is always a top priority.

Position is a Sunday – Wednesday, 4–10-hour shift schedule.

• Coordinate and facilitate QA-related production and production-related activities.
• Prioritize Quality Assurance workload as needed/priorities shift.
• Independently address and report on daily operational issues, as needed.
• Responsible for new employee training, employee growth and development/guidance and conducting performance reviews in a timely and objective manner.
• Review batch-related documentation and ensure resolution of issues to release product.
• Perform overall batch disposition and sign product certificate of analysis.
• Ensure that products are manufactured in compliance with site procedures, regulatory and cGMP guidelines.
• Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
• Participate in site inspections and inspection readiness activities.
• Enhance skills via regular training and continuing…