Quality Assurance Manager responsible for leadership in Quality Management Systems at a biotech company. Ensuring compliance, scalability, and driving culture of quality improvement.
Responsibilities
Provide day-to-day leadership for Quality Management System (QMS) processes and the Quality team
Ensure continued suitability, compliance, and scalability of the QMS
Drive a culture of quality, proactive risk management, and continuous improvement
Own assigned QMS processes end-to-end
Oversee systems/process validation activities
Lead investigations for deviations, nonconformances, and complaints
Plan and execute internal audits
Requirements
Bachelor's Degree in Biology, Chemistry, Life Sciences, Engineering, or related field (required)
8+ years of experience in quality supporting clinical research and/or pharmaceutical/biotech development
3+ years of experience leading others
Demonstrated expertise in QMS processes
Demonstrated experience with Computer System Validation (CSV) in a regulated environment
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