Research Biologics Quality Assurance Manager BioMnf

Overview

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. Lead quality input in process development IND manufacturing and quality control of biologics manufacturing program. 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.

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. Lead quality input in process development IND manufacturing and quality control of biologics manufacturing program. 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.

• 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.

• Requires a MS degree in a scientific discipline or equivalent experience.

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• 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.

• Sitting – Constantly
• Stooping – Occasionally
• Standing – Occasionally
• Talking on the phone or in person – Frequently
• Walking – Occasionally

EOE M/F/Disability/Vet