Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company focused on developing gene therapies with the potential to restore, improve and preserve high-acuity physiologic hearing for people worldwide who live with disabling hearing loss.
Restoring, improving and preserving high-acuity hearing is an area of high unmet need in medicine: 466 million people worldwide have disabling hearing loss, and there are no FDA-approved therapies to address its underlying causes.
Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy. Listening is in our DNA. We believe the only way to achieve our ambitious goals is to engage as one team, listen to each other, and trust in ourselves and our science.
As a key member of the GMP Quality team, day-to-day activities of the Quality Assurance Manager will include review of Master and Executed Batch records, QA support for manufacturing and laboratory deviations/investigations, oversight of Vendor QC testing, data review/ approval, protocol, and report review/ approval, and final disposition of Akouos product. The Manager, QA will also provide QC review of Regulatory Submissions and external publications, including manuscripts and posters. In addition, the candidate will also contribute to QA department improvement projects.
- Support the development of product specifications and analytical method development activities
- QC of Regulatory Submissions and external publications, including manuscripts and posters
- Provide Quality oversight of Contract Testing Labs which include Quality agreements, audits, result reporting, investigations, and metrics
- Review of Master and executed batch production records
- Final Product disposition
- Establish and approve product specifications
- Review and approval of QC analytical methods, method validation protocols and reports, and specifications
- Review and approval of Stability protocols and reports
- Review Change Controls to ensure requirements are met to adhere to SOP requirements
- Perform tracking and trending of analytical data from the Quality Systems (CAPA/Deviation/LIs/OOS/Change Control) and assist in writing and reviewing periodic reports
- Review manufacturing, environmental monitoring, and quality control data for in-process and finished products as part of the investigation process
- Reviews and revises technical registration documents
- Support Annual Product Review preparations and submission (methods, deviations, OOSs)
- Participate in preparation of regulatory inspections and internal and external audits
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements
- Represent Quality as part of tech transfer activities
- Assist with managing reports and presentations to the monthly quality review meetings
- Comfortable working in an environment with minimal direction
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- 5-7+ years of relevant experience in a GMP environment-related field and a BS, or 3+ years of relevant experience and an MS
- Prior experience in the pharmaceutical industry is required; gene therapy and/or biotech experience preferred
- Demonstrates working knowledge of current Good Manufacturing Practices (GMPs)
- Demonstrates working knowledge of quality assurance systems, methods, and procedures
- Demonstrates knowledge of FDA / EMEA standards and quality systems
- Demonstrates basic knowledge of problem-solving and root cause analysis tools used for identifying and correcting deviations
- Demonstrates audit and investigation skills, as well as report writing skills
- Demonstrates good verbal, written, and interpersonal communication skills
- Demonstrates proficiency in Microsoft Office applications