Job Description
Description
Provide quality oversight for CMOs, CDMOs, contract laboratories, and critical suppliers. Review and approve deviations, CAPAs, change controls, investigations, and risk assessments. Support batch disposition and product release activities. Lead quality review of manufacturing and laboratory documentation. Establish and maintain Quality Agreements and Quality Technical Agreements (QTAs). Monitor supplier and CMO performance metrics and drive continuous improvement initiatives. Support technology transfer, process validation, and commercial launch activities. Conduct supplier audits and support regulatory inspections, customer audits, and internal audits. Partner cross-functionally with Manufacturing, Technical Operations, Supply Chain, Regulatory Affairs, Quality Control, and Process Development teams. Ensure compliance with FDA, EMA, ICH, and other applicable global regulatory requirements. Drive inspection readiness and maintain a state of continuous compliance. E...
Provide quality oversight for CMOs, CDMOs, contract laboratories, and critical suppliers. Review and approve deviations, CAPAs, change controls, investigations, and risk assessments. Support batch disposition and product release activities. Lead quality review of manufacturing and laboratory documentation. Establish and maintain Quality Agreements and Quality Technical Agreements (QTAs). Monitor supplier and CMO performance metrics and drive continuous improvement initiatives. Support technology transfer, process validation, and commercial launch activities. Conduct supplier audits and support regulatory inspections, customer audits, and internal audits. Partner cross-functionally with Manufacturing, Technical Operations, Supply Chain, Regulatory Affairs, Quality Control, and Process Development teams. Ensure compliance with FDA, EMA, ICH, and other applicable global regulatory requirements. Drive inspection readiness and maintain a state of continuous compliance. E...
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