Research Biologics Quality Assurance Manager Biomnf

Nationwide Children's Hospital

Main Campus, OH, United States
Quality management program
Biologics manufacturing
Good tissue practice programs
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

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.
  • Approve and release product (investigational drug/device) for use in clinical trials and as appropriate to Good Tissue Practices.

Matching 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.

Skills & Requirements

Must-have

  • Quality Management Program
  • Biologics Manufacturing
  • Good Tissue Practice programs
  • FDA guidelines
  • cGMP training
  • process improvement changes

Nice-to-have

  • leadership in policy formulation
  • client and regulatory inspections
  • collaboration on CAPA projects

Key Requirements

  • MS degree in a scientific discipline or equivalent experience
  • Minimum of five years of quality and regulatory experience
  • Knowledge of current Good Manufacturing Practices

Work Rights

Not specified

Tailored Resume

Cover Letter