About Prevail Therapeutics
Prevail is a New York City-based biotechnology company focused on developing novel gene therapies for Parkinson’s disease and other genetically-defined neurodegenerative diseases. Prevail is based in the Alexandria Center for Life Science.
The Director, Clinical Quality Assurance will support the GXP compliance function at Prevail. Primary responsibilities will include ensuring the compliance of clinical operations with GCPs. The Director, Clinical QA also will provide support with GLPs, GMPs, and Quality Management Systems. The Director, Clinical QA will have a critical role in ensuring regulatory inspection readiness.
As an early hire at a new company, you will have exposure to senior management, to all activities at Prevail, and you will be influential in championing and developing our culture. Our employees are expected to function with a high degree of independence in a fast-paced startup company, while working collaboratively within a multidisciplinary team that is dedicated to the development of new therapies for neurodegenerative diseases.
- Responsible for establishing and implementing Quality Systems documentation requirements including Prevail GCP SOPs for assuring compliance with applicable FDA and other regulatory agency requirements.
- Responsible for Quality Assurance support for strategic and operational activities with Clinical Operations and Clinical Sciences to achieve the successful design and implementation of GCP compliant Quality Systems and clinical trials.
- Execute on plans to improve and grow the GxP Quality System in a timely manner using both internal resources and external relationships with service providers (e.g. CROs).
- Participate in the risk assessment and risk mitigation of clinical development programs from protocol development and conduct of clinical trials to finalization of data analysis and clinical study reports. Collaborate on problem solving and review of Trial Master Files, Clinical Study Reports and related GCP records as part of regulatory filing readiness.
- Serve as a point person (with Clinical Operations) for regulatory and quality inspections of Prevail and Prevail investigator sites, CROs and other service providers.
- Responsible for Prevail GCP training program.
- Responsible for implementation of the Prevail GxP supplier management and audit program including CAPA follow ups with a focus on GCP suppliers and data management efforts.
- Work with Clinical Operations to manage Prevail eTMF and GCP documentation retention activities.
- As needed, work with Pharmaceutical Development on project related drug product manufacturing issues and with Clinical Operations on clinical trial material issues.
- Partner with Clinical Operations to resolve any issues that may arise during clinical development.
- Observes all Prevail policies, SOPs and safety guidelines.
- Other duties as assigned.
- Bachelor’s Degree or above in Life Sciences or related field. Advanced degree in a scientific discipline and hands-on experience in clinical operations preferred.
- Minimum of 10 years of experience in GXP (GCP, GLP, and GMP) activities in the pharmaceutical/biotechnology industry, including quality assurance, is required.
- Experienced with GCP auditing and clinical trial operations in an outsourcing model, including leading investigations with risk assessments for on-going activities in clinical development programs.
- Prior experience interacting FDA and other regulatory agency personnel and understanding of their requirements/expectations.
- Knowledgeable and experienced in implementing FDA, EMA and ICH cGMP, GCP, and GLP regulations and guidelines. Demonstrated ability to ensure compliance.
- Working knowledge of pharmacovigilance and safety reporting requirements.
- Working knowledge of the drug development process for biological products.
- Experienced and proficient computer skills i.e. Microsoft Office, electronic documentation systems (e.g. Veeva) are required. Familiarity with computer validation and 21 CFR 11 compliance.
- Experienced quantitative analytical review skills preferred.
- Knowledge of non-clinical development process and GMP for production of biological products is a plus.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to work professionally with highly confidential information.
- Willingness to work with multiple disciplines on multiple projects in a fast-moving environment, and to value the importance of teamwork. Strong judgement and decision-making skills with the ability to understand how decisions fit into corporate strategies.
We offer competitive compensation and benefits, including paid time off, health insurance, life insurance and flexible spending accounts. Prevail is an Equal Opportunity Employer.
Please apply by sending your CV to firstname.lastname@example.org.