At Neurogene, we are working to provide medicines to improve the lives of neurologically impaired children and their families. We envision a world in which all families have access to genetic medicines, even if the disorder is exceedingly rare. For children, our goal is to enable them to have a healthier future. For families, we want to make their lives better by easing the challenges of caring for someone with a devastating neurological disorder. As an employee of Neurogene, you will be part of a culture helping to make this dream a reality, collaborating with people in a start-up environment, whose mission is to improve the lives of the patients we serve and make the world a better place.
Reporting to the SVP, Regulatory Affairs, the Director, Clinical QA, is responsible for interacting with a team of professionals with an overall objective to strategically direct Clinical QA activities that provide an independent assessment (IA) of activity specifically related to Neurogene’s GCP, GLP, and PV regulated processes and programs. The individual in this role will have an in-depth understanding and knowledge of appropriate regulatory compliance and other applicable regulations and laws, procedures, and appropriate processes, which allows the individual to plan and conduct internal and external audits independently.
Accountabilities and Responsibilities
- Responsible for assuring the quality of clinical systems, processes and related activities.
- Ensures clinical programs, including clinical trials, meet global regulatory and company requirements.
- Manage and conduct both internal and external quality audits, while supporting a compliance culture and process improvement.
- Implement and maintain a risk-based QA audit program to oversee pre-clinical (GLP), clinical (GCP and PV), and post-approval (PV) programs. Lead qualification, routine and for-cause audits of external service providers, including CROs, investigator sites, non-clinical labs, laboratory and data management vendors, and other vendors to assess the effectiveness of their GxP compliance and adherence to approved study protocols and contracts.
- Conduct internal and external document reviews and audits, including regulatory application documentation, protocols, study reports, and Trial Master File documents.
- Act as the liaison for Clinical trial-related activities, including clinical meeting representation and review of clinical procedures and procedural documents.
- Lead inspection readiness activities related to company and vendor inspections by regulatory authorities.
- Coordinates tracking of document requests and responses.
- Bachelor’s degree in life science or equivalent experience gained by working in relevant areas (clinical research setting, laboratory, etc.)
- Minimum 12 years of experience, including GCP auditing experience of early phase and late phase clinical trials; CRO, Pharma, or Biotech industry
- Licenses • Related certifications (ASQ, SQA, ISO) preferred
- Knowledge & Skills • Thorough understanding of Good Clinical Practices and FDA Part 11 (electronic documentation)
- Knowledge and experience of other GxPs (GLP, GMP, PV, GDP, GPP, etc.) preferred
- Experience hosting sponsor audits and regulatory inspections highly preferred
- Experience with audit programs for cell or gene therapy programs
- Experience managing an audit team
- Demonstrated success in business, functional and people management
- Consistently demonstrates clear and concise written and verbal communication
- Demonstrated ability to remain unbiased in a diverse working environment
- Effective negotiation skills
- High degree of flexibility and ability to adjust to changing priorities and unforeseen events