Job Summary
The Quality Audit Manager plays a crucial role in formulating and implementing the GxP Quality Audit Program, which encompasses internal audits as well as those conducted on suppliers and partners. This position entails providing strategic oversight for ensuring readiness for inspections, planning audits, and enhancing the Quality Management System through continuous improvement initiatives.
Responsibilities
- Develop and execute the GxP Quality Audit Program.
- Conduct internal, supplier, and partner audits to ensure compliance and quality standards.
- Lead strategic efforts to prepare for inspections and audits.
- Facilitate audit planning and coordinate activities to enhance effectiveness.
- Drive the continuous improvement of the Quality Management System.
Qualifications
- Bachelor’s degree in a relevant scientific or technical discipline.
- A minimum of 7 years of experience in Quality Assurance or GxP compliance.
- At least 3 years of direct experience in auditing.
- Expertise in risk-based GxP auditing methodologies.
Neurona Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
