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Quality Assurance Operations Specialist

Boston, MA
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.

Job Summary:

The Quality Group is seeking a motivated Quality Assurance professional to perform Quality Operations at Akouos. This individual will assess the regulatory landscape and ensure requirements are translated and applied appropriately across Akouos’s GxP activities, including GMP manufacturing, GLP nonclinical studies, and GCP clinical trials and supportive studies. The candidate will be responsible for ensuring end-to-end quality operations for internal and external manufacturing, electronic quality management system (eQMS) implementation and maintenance, as well as operations support for broader GxP Quality activities (training, controlled document maintenance and compliance, oversight of GxP [e.g., GLP, GCP, GCLP, GVP] vendors). 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.

Job Responsibilities:
  • Lead the development, review, and approval of SOPs; support manufacturing, QC, nonclinical, and clinical teams in the establishment of and compliance with these controlled documents
  • Support the business in management of GxP vendors (supplier qualification, supplier audits, development of audit plans, reports and quality agreements)
    • Review and maintain quality agreements
    • Perform and manage others in performing audits and surveillance of vendors
  • Manage training curricula, training records, and ensure ongoing compliance to training requirements for internal GMP and oversight of external GxP activities
  • Review and approve process validation protocols and reports as well as master batch records and associated GMP documents used by Akouos and Akouos’s vendors
  • Review and approve risk assessments, change controls, deviations, investigations, and associated CAPAs; lead complaint investigations
  • Support the implementation of an eQMS to facilitate compliance across Akouos; lead the implementation and maintenance of the QMS across the key stakeholder functions
  • Partner with relevant internal and external teams to highlight potential quality issues (e.g., during process transfer, manufacturing, and testing); identify / execute strategies to effectively manage them
  • Partner with manufacturing on:
    • Development of the overall control strategy (e.g., in process, release, stability testing and respective acceptance criteria)
    • Review trended product data and monitoring plans, and assess impact of process changes and effectiveness of change controls on product quality
    • Identification of opportunities for improvement
  • Review regulatory submissions, as needed
  • Assure a state of regulatory inspection readiness
Job Qualifications:
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 7 years relevant experience, including 3 years of direct QA Operations experience in a regulated industry; hands-on GMP quality assurance operations experience, including batch record review and disposition, 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 is essential
  • Extensive investigation, deviation management, and monitoring skills
  • Strong knowledge of eQMS systems, preferably including initial implementation
  • In addition to remote audits and oversight, limited travel (< 10%) for vendor / supplier audits and visits may be required
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