Research Biologics Quality Assurance Manager Biomnf

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Quality management program development
Cgmp training for staff
Biologics manufacturing quality oversight
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.
  • Manage under the direction of the Director of Research Compliance & Integrity the implementation of quality management systems in relation to Quality Assurance in order to ensure product safety and regulatory compliance.
  • 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 development
  • cGMP training for staff
  • Biologics manufacturing quality oversight
  • Good Tissue Practice compliance
  • Internal and external audits

Nice-to-have

  • Leadership in regulation policy
  • Collaboration on continuous improvement

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
  • Experience with cGMP practices for biological products and cell cultures

Work Rights

Not specified

Tailored Resume

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