Research Biologics Quality Assurance Manager Biomnf
stantonlab.info
Main Campus, OH, United States
On-site
Quality management program implementation
Biologics manufacturing quality control
Cgmp training to staff
The Research Biologics Quality Assurance Manager position at StantonLab involves leading the development and implementation of quality management programs for biologics manufacturing. The role requires ensuring regulatory compliance, managing quality systems, and collaborating with various teams to improve processes
Job Summary
Provide leadership in formulating regulation policy including resource management and development, implementation, and maintenance of a Quality Management Program for the Phase 1/2A IND, Biologics and Good Tissue Practice programs.
Establish and maintain appropriate quality system to ensure compliance with regulatory requirements, including controlled documents like Quality Management Plan and SOPs.
Work closely with Scientists, Biologics and Facility Management Teams for deviation investigations, process change controls and implementation of process improvement changes.
Matching Summary
Match Score: 85
The Research Biologics Quality Assurance Manager position at StantonLab involves leading the development and implementation of quality management programs for biologics manufacturing. The role requires ensuring regulatory compliance, managing quality systems, and collaborating with various teams to improve processes.
Skills & Requirements
Must-have
Quality Management Program implementation
Biologics manufacturing quality control
cGMP training to staff
Process development quality input
Regulatory inspections representation
Nice-to-have
Continuous improvement and CAPA projects
Client and regulatory inspection representation
Key Requirements
MS degree in a scientific discipline or equivalent experience
Minimum of five years of successful quality and regulatory experience
Knowledge and expertise in current Good Manufacturing Practices
Experience with cGMP practices relative to biological products and cell cultures