Nationwide Children's Hospital · 4 weeks ago
Research Biologics Quality Assurance Manager BioMnf
Columbus, OH
Full-time
Onsite
Senior Level
5+ years expNationwide Children's Hospital is seeking a Research Biologics Quality Assurance Manager to lead the formulation of regulation policy and manage the Quality Management Program for biologics. The role involves ensuring compliance with regulatory requirements, overseeing quality systems, and collaborating with various teams for process improvements and audits.
ChildrenHealth CareMedical
Responsibilities
Establish and maintain appropriate quality system to ensure compliance with regulatory requirements
Register, distribute and maintain controlled documents including but not limited to Quality Management Plan, Batch Record Documents, Standard Operating Procedures (SOPs), Master Validation Plans, Validation Protocols and Quality Assurance Manual
Represent the Biologics Manufacturing Facility during client and regulatory inspections
Represent the Research Institute (RI) during regulatory inspections
Ensure that requirements for quality systems are met according to FDA guidelines and industry standards for the manufacture of biologics and an overall program for Good Tissue Practices
Work closely with the Scientists, Biologics and Facility Management Teams for deviation investigations, process change controls and implementation of process improvement changes
Perform internal and external audits to ensure compliance with regulatory and internal guidelines
Provide cGMP training to staff on a continuing basis
Provide oversight to product development including raw material technical specifications and supplier selection
Approve and release product (investigational drug/device) for use in clinical trials and as appropriate to Good Tissue Practices
Assign and delegate responsibilities to Biologics QA Auditors
Develop and collaborate with Biologics Manufacturing Leadership on continuous improvement and CAPA projects
Qualification
Required
Requires a MS degree in a scientific discipline or equivalent experience
Knowledge and expertise in the principles of current Good Manufacturing Practices
Strong technical documentation and auditing skills with the ability to work with complex details
Experience with cGMP practices relative to biological products and cell cultures
Minimum of five years of successful quality and regulatory experience
Company
Nationwide Children's Hospital
Nationwide Children’s, we are creating the future of pediatric health care. We consider every detail. Every decision. Every aspect
10001+ employees
H1B Sponsorship
Nationwide Children's Hospital has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (38)
2024 (24)
2023 (22)
2022 (16)
2021 (14)
2020 (16)
Funding
Current Stage
Late StageTotal Funding
$4.1MKey Investors
National Institute of Neurological Disorders and StrokeNational Heart, Lung and Blood Institute
2024-03-04Grant· $4.1M
2023-09-19Grant
Leadership Team
Chet Kaczor
Senior Vice President Operations
Recent News
2026-01-03
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