Our Mission: Healthy hearing available to all.
Akouos, a wholly owned subsidiary of Eli Lilly and Company, is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for inner ear conditions, including forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and gene therapy.
The Clinical Quality Assurance Group is seeking a motivated Quality Assurance professional to manage Quality Operations at Akouos. The candidate will be responsible for supporting end-to-end quality operations (e.g., training, controlled document lifecycle and compliance, QMS/e-system maintenance). 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.
Reporting to the Head of Clinical Quality Assurance, the successful candidate will promote collaboration to ensure all systems, processes, and their outcomes are compliant with regulatory requirements, Akouos standard operating procedures (SOPs), guidelines, and best practices.
- Support the development, review, and approval of controlled documents such as: SOPs, policies, work instructions, and associated forms across applicable GxP functions including nonclinical and clinical teams
- Manage training learning plans and training records
- Support the establishment, maintenance, and/or integration of Clinical eQMS and eClinical systems
- Support the development of quality reports and trending metrics
- Maintain Clinical Quality Assurance files, dashboards, and trackers
- Other duties as assigned
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 a minimum of 3 years relevant experience, including 2 years of direct QA Operations experience in a regulated industry; hands-on Clinical quality assurance operations experience, including training compliance and systems implementation for GCP and GVP activities preferred
- Strong leadership and collaborative skills with demonstrated ability to build and manage strong networks throughout the organization
- Excellent interpersonal skills including team-oriented approach with ability to work in fast paced, rapidly changing environment with strong communication, training, and presentation skills
- Attention to detail and implementation of good documentation and GxP processes are essential
- Working knowledge of pharmaceutical regulations, standards, and current industry practices in ICH/GCP, Quality Management System/audit procedures, reporting, and CAPA management
- Strong knowledge of QMS and eClinical systems, preferably including initial implementation
- Strong analytical and organizational skills with strong attention to detail
- Ability to work independently in a fast-paced rapidly changing environment
- Experience in gene therapy product development is ideal
- Limited travel (< 10%) may be required
Akouos is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.