Location
Waltham
Job Type
Full-time
Posted
July 15, 2026
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 globa...
+ 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 globa...
Ready to Apply?
Submit your application for Senior Quality Assurance Consultant at Actalent
Apply Now