Research Biologics Quality Assurance Manager Biomnf
Nationwide Children's Hospital
Cgmp principles for biological products
Regulatory inspection representation
Batch record document maintenance
This role provides leadership in formulating regulation policy and maintaining a Quality Management Program for Phase 1/2A IND and Biologics programs
Job Summary
This role provides leadership in formulating regulation policy and maintaining a Quality Management Program for Phase 1/2A IND and Biologics programs.
The incumbent will represent the facility during client and regulatory inspections to ensure compliance with FDA guidelines and Good Tissue Practices.
Responsibilities include approving and releasing investigational drug products for clinical trials while managing deviation investigations and process change controls.
Matching Summary
This role provides leadership in formulating regulation policy and maintaining a Quality Management Program for Phase 1/2A IND and Biologics programs.
Skills & Requirements
Must-have
cGMP principles for biological products
regulatory inspection representation
batch record document maintenance
deviation investigation and CAPA
internal and external audit execution
Nice-to-have
process improvement collaboration
supplier selection oversight
continuous improvement mindset
cross-functional team leadership
Key Requirements
MS degree in scientific discipline or equivalent experience
Minimum of five years quality and regulatory experience
Experience with cGMP practices for biologics and cell cultures