Senior Manager, Quality Assurance - Clinical​/Non-Clinical Quality

Join us as a Sr. Manager, Quality Assurance, Clinical/Non-Clinical Quality!

Join Abeona Therapeutics as a Sr. Manager, Quality Assurance, Clinical/Non-Clinical Quality 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 onsite (remote may be considered for the right candidate) Monday to Friday (some late or weekend work may be required) from 9:00 to 5:00 (start and end times may vary) and contribute to impactful products that change people's lives. With a competitive salary of $110,000 to $132,000 per year (plus annual discretionary bonus and equity opportunity), 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 Sr. Manager, Quality Assurance, Clinical/Non-Clinical Quality at Abeona Therapeutics, your day-to-day activities will focus on executing and supporting quality programs and oversight of daily quality assurance activities supporting clinical operations and non‑clinical studies. This person will work with cross functional team members of Abeona. The role will control document lifecycle activities, perform verification and auditing of data generated during clinical/non‑clinical studies, develop and lead quality oversight programs, ensure compliance with the FDA, EMA, and ICH, coordinate CGP/GLP audits, and will play a key role in coordinating information and guidance for internal and external stakeholders to ensure compliance with relevant standards and regulations.

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 Monday to Friday (some late or weekend work may be required) during the first shift, from 9:00 – 5:00 (start and end times may vary) (with some late night or weekend work on occasion).

To thrive as a Sr. Manager, Quality Assurance, Clinical/Non‑Clinical Quality, the right combination of experience, education, skills, and attitude is essential.

This role requires a high level of independent expertise and practical experience with the review of clinical study data, SAS datasets, clinical study reports, case report forms, and data listings in the biopharmaceutical or pharmaceutical space. The ability to communicate as an SME to internal staff of various backgrounds, as well as external CRO and regulatory bodies is essential to being successful in this position.

Do you enjoy planning ahead, developing SOPs, interpreting…