Abeona Therapeutics Inc. (NASDAQ: ABEO) is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases.
We believe emerging insights in genetics and advances in biotechnology, as well as new approaches and collaboration between researchers, industry, regulators and patient groups, provide significant opportunities to develop breakthrough treatments for rare diseases.
The Director of Quality Assurance at Abeona Therapeutics, Inc., is part of the management team of the company. The overall mission of this position is to assure that the company is compliant with regulatory agencies that govern manufacturing and distribution of products. The Director of Quality Assurance reports to the VP, Therapeutics Development and Quality Management of the company and is responsible for the development, implementation and oversight of the company’s quality policies and Quality Plan. The Director of Quality Assurance may become or be certified at hire to be the Quality Person (QP).
To be qualified for this role, the successful candidate must have previous Quality Assurance oversight experience in a Biologics manufacturing environment, have intimate knowledge of both FDA and ICH guidelines, product submission experience, and strong expertise in statistical analysis and audit management.
- Implement and oversee the Quality Plan for the company, along with other senior management
- Develop the Quality Systems necessary for compliance with the FDA cGMPs, and other agencies as necessary
- Develop the “risk analysis” systems and ensure that the quality improvement program is based on the best applicable science and technology
- Develop a facilities validation master plan for each product and process
- Develop the documentation system to support the validation master plans
- Develop and maintain systems dossiers for infrastructure and equipment
- As the fiduciary for company management, be responsible for the final release of any product
- Train QA staff
- Develop quality training programs for employees and management
- Develop audit systems for vendors and contract manufacturers and specialty services suppliers
- Work with the clinic, manufacturing, and research to anticipate quality issues as new products, processes, and analytical procedures are developed
- PhD or equivalent in a relevant scientific discipline (biochemistry, physiology, bioengineering, immunology)
- 15-20 years industrial biopharmaceutical experience
- Strong management and organizational skills
- Strong interpersonal skills
- Previous successful interactions at multiple levels with the FDA and other regulatory agencies
- Current working understanding of molecular biology, immunology, cell biology and virology
- Experience in the manufacture of patient-specific therapies
- Experience in pharmaceutical sciences
- Working understanding of computerized information management from both hardware and software standpoints
- Practical experience in facilities design, construction, operation and maintenance
- Practical business management experience including budget management and personnel management
- Current working understanding of international biopharmaceutical regulatory agencies and protocols2