| The Manager, Quality Assurance supports the electronic management of entries in the Enterprise Quality Management System (EQMS), to support Good Manufacturing Practices (GMP) compliance at the Abeona Therapeutics Inc. site in Cleveland, OH. This role will be responsible for leading, writing, and managing quality investigations related to deviations, non-conformances, out-of-specification (OOS) results, CAPAs, and Change Controls within a GMP-regulated cell and gene therapy manufacturing environment. The ideal candidate will bring experience in root cause analysis, strong scientific acumen, and an ability to work cross-functionally to ensure timely, compliant, and effective resolution of quality issues. This role serves as an embedded quality assurance representative within various GMP departments/functional groups. |
| Essential Duties and Responsibilities |
Position is Day Shift with occasional weekends (as needed). - Performs the following duties with minimal supervision.
- Lead and manage the deviation, investigations, CAPA, and Change Control program across Manufacturing, QC, and other GxP functions.
- Supervise a team of Quality Investigators and/or specialists responsible for conducting and writing deviations, investigations, CAPAs, and Change Controls.
- Provide subject matter expertise (SME) in deviation handling, root cause analysis, CAPA definition, and effectiveness checks.
- Ensure investigations are conducted to high quality standards, meet regulatory expectations, and are completed within established timelines.
- Review deviations, investigations, CAPAs, and Change Controls for scientific accuracy, regulatory compliance, and clarity.
- Identify trends and systemic issues from investigation data; lead cross-functional initiatives to reduce repeat deviations and improve processes.
- Serve as the investigations SME during regulatory inspections and internal audits; prepare and present investigation summaries and metrics.
- Own and/or continuously improve SOPs, workflows, and tools related to investigations, CAPA, Change Control and deviation management.
- Collaborate closely with Manufacturing, Quality Control, Supply Chain, Facilities, Engineering, and Regulatory Affairs.
- Support the development and delivery of training on investigation techniques and quality event reporting.
- Support site inspections, as needed.
- Perform other duties as required.
|
| Qualifications |
- Minimum of a Bachelor’s degree in Life Science, Engineering, or a related field and/or equivalent experience.
- Minimum of 7 years of experience in quality and/or in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
- 2+ years of direct team management or leadership experience.
- Deep knowledge of cGMPS, ICH Q9 (Quality Risk Management), FDA regulatory expectations.
- General knowledge of aseptic manufacturing processes.
- Proven experience in investigation writing, root cause analysis, and CAPA management.
- Experience leading teams, developing personnel, and fostering a high-performance culture.
- Strong project management skills and ability to manage multiple priorities in a fast-paced environment.
- Proficient in electronic QMS tools (e.g., Veeva, MasterControl, TrackWise, etc.).
- Collaborative team player with strong problem-solving skills and attention to detail.
|
| 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 technical writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.
- Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.
- Training or certification in investigation techniques (e.g., TapRoot, Kepner-Tregoe)
|
| 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. |
| The Manager, Quality Assurance supports the electronic management of entries in the Enterprise Quality Management System (EQMS), to support Good Manufacturing Practices (GMP) compliance at the Abeona Therapeutics Inc. site in Cleveland, OH. This role will be responsible for leading, writing, and managing quality investigations related to deviations, non-conformances, out-of-specification (OOS) results, CAPAs, and Change Controls within a GMP-regulated cell and gene therapy manufacturing environment. The ideal candidate will bring experience in root cause analysis, strong scientific acumen, and an ability to work cross-functionally to ensure timely, compliant, and effective resolution of quality issues. This role serves as an embedded quality assurance representative within various GMP departments/functional groups. |
| Essential Duties and Responsibilities |
Position is Day Shift with occasional weekends (as needed). - Performs the following duties with minimal supervision.
- Lead and manage the deviation, investigations, CAPA, and Change Control program across Manufacturing, QC, and other GxP functions.
- Supervise a team of Quality Investigators and/or specialists responsible for conducting and writing deviations, investigations, CAPAs, and Change Controls.
- Provide subject matter expertise (SME) in deviation handling, root cause analysis, CAPA definition, and effectiveness checks.
- Ensure investigations are conducted to high quality standards, meet regulatory expectations, and are completed within established timelines.
- Review deviations, investigations, CAPAs, and Change Controls for scientific accuracy, regulatory compliance, and clarity.
- Identify trends and systemic issues from investigation data; lead cross-functional initiatives to reduce repeat deviations and improve processes.
- Serve as the investigations SME during regulatory inspections and internal audits; prepare and present investigation summaries and metrics.
- Own and/or continuously improve SOPs, workflows, and tools related to investigations, CAPA, Change Control and deviation management.
- Collaborate closely with Manufacturing, Quality Control, Supply Chain, Facilities, Engineering, and Regulatory Affairs.
- Support the development and delivery of training on investigation techniques and quality event reporting.
- Support site inspections, as needed.
- Perform other duties as required.
|
| Qualifications |
- Minimum of a Bachelor’s degree in Life Science, Engineering, or a related field and/or equivalent experience.
- Minimum of 7 years of experience in quality and/or in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
- 2+ years of direct team management or leadership experience.
- Deep knowledge of cGMPS, ICH Q9 (Quality Risk Management), FDA regulatory expectations.
- General knowledge of aseptic manufacturing processes.
- Proven experience in investigation writing, root cause analysis, and CAPA management.
- Experience leading teams, developing personnel, and fostering a high-performance culture.
- Strong project management skills and ability to manage multiple priorities in a fast-paced environment.
- Proficient in electronic QMS tools (e.g., Veeva, MasterControl, TrackWise, etc.).
- Collaborative team player with strong problem-solving skills and attention to detail.
|
| 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 technical writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.
- Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.
- Training or certification in investigation techniques (e.g., TapRoot, Kepner-Tregoe)
|
| 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. |
