Head of Clinical Quality Assurance


Boston, MA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 02/12/2021
  • Website: akouos.com
  • Company Address: 645 Summer St, suite 200, Boston, MA

About Akouos

Akouos is a biotechnology company focused on restoring and preserving hearing.

Job Description

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 Clinical Quality Assurance professional to oversee quality and regulatory compliance related to Clinical Development, Clinical Operations, Pharmacovigilance, and other related activities performed by the Clinical and Medical groups at Akouos. The successful candidate will assess the regulatory landscape and ensure requirements are translated and applied appropriately across Akouos’s R&D activities, including the application of GCP to clinical trials and supportive studies.

Reporting to the Chief Operating Officer, the successful candidate will provide leadership and promote collaboration to ensure all systems, processes, and their outcomes are compliant with regulatory requirements, Akouos standard operating procedures, guidelines, and best practices. The individual will be self-motivated, with a desire to succeed at the highest level, working with teams to develop gene therapies with the potential to restore, improve, and preserve hearing.

Job Responsibilities:

  • Proactively provide GCP QA leadership, guidance, and support to clinical development/operations activities to ensure patient safety, data integrity, and operational efficiency
  • Lead the implementation of GCP-compliant procedures and operations to ensure a robust quality management system for both clinical studies as well as eventual commercial-stage biologic/combination products
  • Lead efforts to evaluate and contribute to clinical program design and execution (e.g., protocols, ICFs, CAPAs, CSRs)
  • Provide GCP compliance oversight of CROs, vendors, and clinical sites
  • Manage training curricula, training records, and ensure ongoing compliance to training requirements for internal GCP/GVP activities and oversight of external GCP/GVP activities
  • Responsible for the maintenance and further development of CQA Standard
  • Provides business oversight and strategic guidance for key clinical systems, such as LMS, eTMF, CTMS, and clinical QMS
  • Establish robust GCP/GVP audit plans (vendor qualification/performance audits, clinical investigator site audits, and internal systems audits)
  • Lead clinical quality investigations, including generation and follow-up of deviations and Corrective and Preventative Action (CAPA) plans
  • Develop, track, and report compliance metrics
  • Assist in preparation and review of clinical regulatory filings and safety data reports (e.g., annual reports, eventual marketing applications) to ensure compliance with SOPs and regulatory standards
  • In coordination with GMP Quality colleagues, lead efforts to ensure inspection readiness, ensuring organization preparation, coordination, and documentation of regulatory inspections
  • Serves as the Lead in the coordination, preparation for, and management of GCP/GVP related inspections by Regulatory Authorities (including pre-inspection activities, as well as follow-up activities)
  • As Akouos’s programs progress through clinical development, hire and manage CQA team members to ensure efficient and effective CQA operations
  • Promote a culture of quality across Akouos, reflecting Akouos core values predicated on respect, trust, and transparency

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 is required with minimum of 10 years’ experience in Pharmaceutical or Biotechnology and/or Medical Device Quality Assurance (in sponsor companies, CROs, or GCP consulting), with at least 5 years’ global GCP/GVP specific experience
  • Expert knowledge of pharmaceutical regulations, standards, and current industry practices in the area of GCP/GVP, Quality Management System/audit procedures, reporting, and CAPA management
  • Experience interacting with FDA, EMA, and other global health authorities
  • Experience with building a GCP culture in a start-up environment is preferred
  • Experience in gene therapy product development is ideal
  • Strong analytical and organizational skills with strong attention to detail
  • Ability to integrate seamlessly with key stakeholders and build strong partnerships across key functions to drive a culture of compliance
  • Ability to work independently in a fast-paced rapidly changing environment

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.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.