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.
The Quality Group is seeking a dedicated Quality Assurance Manager to oversee quality control testing of materials and reference standards, and going forward assist with oversight of GMP manufacturing for gene therapy product candidates. This role will be responsible for oversight of QC testing and material management, assuring all equipment is appropriately maintained, sample management, batch release, environmental monitoring, and assisting on deviation/investigation management, OOS/OOT investigations, CAPA and change control follow-up and implementation. The individual will be self-motivated, with a desire to succeed at the highest level, working with teams to develop therapies with the potential to restore, improve, and preserve hearing.
- Partner with QA colleagues, QC and Analytical Development teams, manufacturing teams, vendors, equipment vendors, suppliers, and facilities, to provide quality input, and review and approval (as needed), of key documents, including, but not limited to:
- Change control documents
- Laboratory methods and validation reports
- Testing specifications
- Analytical results
- Stability reports
- Non-conformance reports
- Support equipment validation and maintenance program
- Support the development and enhancement of Akouos procedures related to GMP compliance, quality management systems, document management and control, annual product reviews, and training
- Input into method validation and tech transfer (as required)
- Support, as required, the implementation and maintenance of the electronic Quality Management System, as well as development of key performance indicators and metrics to monitor effectiveness of quality as related to manufacturing, quality control, materials management, vendor performance and others measures of quality, consistency, and reliability
- Provide support and guidance for the resolution of investigations, deviations, CAPAs, change controls, and other quality systems issues
- Keep current with industry trends and methodologies relevant to GxP
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.
- Bachelor’s degree with minimum 7 years experience in a regulated industry and in-depth knowledge of manufacturing of biologicals, ideally gene or cell therapy products
- In-depth knowledge of QA/QC documentation requirements and best practices
- Excellent interpersonal skills including team-oriented approach with ability to partner with others in fast paced, rapidly changing environment.
- Significant experience in the generation, review, and monitoring of controlled documents such as SOPs, control test records, materials and product specifications, policies and other procedures as related to GxP compliance and operations
- Experience in developing and using certificate of analyses, certificates of testing, and certificates of compliance as applied to areas of responsibility
- Thorough knowledge of process and vendor performance metrics and key performance indicators and methods to monitor and track such metrics
- Attention to detail and implementation of good documentation and QC processes is essential.
- Excellent knowledge of:
- QA/QC processes and documentation required for compliance to regulatory requirements
- QC testing methods and associated documentation
- Manufacturing testing methods and associated documentation
- Batch record review and product and materials disposition
- Strong written communication and presentation skills are essential.