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, the Director of GMP Quality Systems will oversee GMP quality systems and processes supporting the overall success of our potential genetic medicines. This position will support the organization by establishing a compliant, phase appropriate Quality Management Systems (QMS) aligned with industry standards and best practices. The Director GMP Quality Systems will be responsible for the development, maintenance, and continual improvement of Quality Events, CAPA, change control, audit management, inspection readiness, document control, risk management, training and quality metrics. These activities will encompass IND-enabling, clinical, and commercial cGMP initiatives.
- Manage/Oversee and further develop the QMS to support early-stage clinical, late-stage clinical, and future commercial cGMP operations.
- Lead the development, implementation, and enhancement efforts of electronic quality management systems.
- Ensure that all documentation regarding the Quality Management System is effectively maintained
- Responsible for developing and overseeing the training programs, inspection readiness programs, and internal/external audit programs
- Provide subject matter expertise to assure Quality Events, Root Cause Analysis, CAPA, effectiveness checks, and change controls to meet current regulatory requirements and industry practices
- Directs and provides feedback on root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements
- Develop and manage the Akouos risk management process
- Lead risk assessment initiatives in close collaboration with internal and external interfaces
- Understand quality processes and systems to troubleshoot problems and anomalies to provide compliant and practical solutions to meet user needs
- Take ownership of issues and collaborate with IT Help Desk and vendors to drive issues to full resolution for stakeholders and customers for quality systems
- Compile and evaluate quality metrics for Quality Management Review
- Business owner of quality management systems (e.g. eQMS)
- Assure appropriate notification and escalation of adverse trends; lead Continuous Improvement initiatives
- Develop, manage, and communicate Akouos training requirements and initiatives
- Provide innovative ideas to advance training effectiveness and share best practices
- Foster a quality mind-set within Quality, Tech Ops, and throughout the company by ensuring consistent, risk-based, and innovative thought processes are employed to advise and make decisions
- Work cross-functionally to support the development and update of policies and procedures in support of Akouos Quality Systems
- Facilitate or support inspections by regulatory authorities and maintain a state of inspection readiness
- Recruit, coach, and develop organizational talent
- Support clinical and commercial cGMP quality activities when needed
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.
- BS or MS in a scientific discipline with at least 10 years of work experience in the Pharmaceutical/Biotechnology industry with at least 5 years in GMP Quality, ideally early clinical development through commercial drug product (an equivalent combination of education and experience may be considered)
- Minimum of 3 years managerial experience
- Demonstrated success in the design, implementation, and management of innovative quality systems (eDMS, eQMS, training)
- Expert knowledge of FDA, EMA, and ICH GMP and other GxP regulations and guidelines
- Risk management experience (FMEA, PHA, etc.).
- Experience in hosting FDA and Health Authority inspections
- Excellent people leader with strong coaching, mentoring, and decision-making skills
- Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams in a fast growth environment
- Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment
- Ability to think strategically and to influence others
- Ability to communicate and work effectively at multiple levels within the organization
- Ability to organize and judge priorities
- Ability to identify, prioritize, and implement actions to continuously improve systems and manage risks
- Advanced computer, word processing, spreadsheet, and database skills