Job description
Senior Director, Clinical Quality Assurance
Join our team dedicated to curing rare diseases! We value our team members' growth and well-being as much as our scientific progress. We seek collaborative, hands-on individuals passionate about making a difference for patients. This is an opportunity to be part of a small, dynamic team and contribute to an innovative biotechnology organization.
Position Summary
We are looking for a motivated individual to lead Clinical Quality Assurance Operations, ensuring compliance and readiness through proactive planning and execution of audits, trend analysis, corrective actions, and risk evaluations. This role is crucial in our mission to bring hope and relief to patients with rare diseases. Success in this role requires collaboration and the ability to work in a fast-paced environment.
Responsibilities
- Implement and manage the Quality Management System.
- Develop and execute readiness plans and activities.
- Provide training based on audit and inspection findings.
- Prepare audit plans and conduct audits of clinical sites and service providers.
- Resolve compliance issues and provide technical support.
- Review clinical trial documentation for data integrity and compliance.
- Support vendor selection and qualification activities.
- Ensure compliance with delegated responsibilities.
- Participate in process improvement projects.
- Evaluate new regulations and update the quality program as needed.
- Provide guidance on data integrity and documentation practices.
- Prepare and deliver training materials.
- Promote organizational values and behaviors.
Qualifications
- Advanced degree in Life Sciences.
- Extensive clinical experience in the pharma/biotech industry.
- Proven leadership skills.
- Experience with clinical site audits.
- Knowledge of risk-based methodologies.
- Experience in vendor management.
- Familiarity with clinical regulations and guidelines.
- Proficiency in Microsoft applications.
- Strong communication and organizational skills.
- Problem-solving ability.
- Experience in rare disease or cell or gene therapy preferred.