Manager, Quality Assurance

JOB TITLE MANAGER, QUALITY ASSURANCE – QUALITY OPERATIONS

Department Quality Assurance – Quality Operations

Reports To Director, Quality Assurance or above

Ladder Level - 5

DESCRIPTION

Position Overview

The Manager, Quality Assurance oversees routine activities associated with 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, in-process

sampling / testing, primary and secondary packaging, label control, and document management

ensuring procedural and regulatory compliance throughout the manufacturing process. The Manager,

Quality Assurance will report to the Director, Quality Assurance or above.

Essential Duties and Responsibilities

Position is on a rotating 4-10 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 hire 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
• Provide Quality Assurance oversight and approval to support manufacturing operations and product/testing approval and/or release.
• 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.
• Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
• Participate in site inspections and inspection readiness activities.
• Participate in regular meetings with the appropriate departments to develop and/or improve processes.
• Enhance skills via regular training and continuing education, including professional society membership/participation.
• Completion of gowning qualification and maintaining status for entry into Aseptic processing area.
• Must be able to demonstrate a sound knowledge of aseptic gowning practices.
• Author, Approve or Authorize documents as assigned. Documents include but are not limited to: Master Production Records, Quality Control test methods/forms, Method Qualification/Validation records, etc. Authorization includes a review of the content for applicability in connection with customer audit/inspections as well as GMP compliance.
• Perform other duties as required.

Qualifications

• Minimum of a Bachelor’s degree in related field and/or equivalent experience.
• Minimum of 7-10 years of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
• Working knowledge of quality operations and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.