Quality Systems Specialist
BioPharma Consulting JAD Group
N/A
The Specialist of Global Quality Systems will serve as the Process enabler and support for critical quality processes including Deviations, Corrective and Preventive Actions (CAPA), Change Control, Regulatory Intelligence, and Training within a global biotechnology environment. This role is essential in maintaining quality excellence and regulatory compliance across the enterprise while ensuring processes remain efficient and fit for purpose.
Key Responsibilities
- Process Support
- Serve as global process support for Deviation, CAPA, Change Control, Reg Intel, and Training processes
- Facilitate analysis of Quality Systems metrics and performance periodically
- Manage Quality Systems deviations and CAPAs, ensuring proper investigation, resolution, and preventive measures
- Oversee Regulatory Intelligence assessments and maintain associated documentation
- Facilitate the Change Control Review Board and maintain...