Manager, QC
Core
Lead the Quality Control team to oversee mold monitoring, incoming material control, in-process and finished goods inspection, and batch release activities in a cGMP manufacturing environment.
Role type
Senior IC Quality Control Manager
Builds
Injectable medicines and medical devices
Domain
Pharmaceutical/Medical Device Manufacturing
Required skills
cGMP compliance, batch release management, root cause analysis, CAPA implementation, team leadership, data trend analysis, inspection plan creation, technology transfer support, SAP proficiency, regulatory standards knowledge (ISO 9001, ISO 15378)
Preferred skills
Pharmaceutical/medical device manufacturing experience, Six Sigma/A3 problem-solving, gamma irradiation certificate review, cross-functional project management
Technologies
SAP
Responsibilities
Manage QC team execution of sampling, testing, and inspections; oversee incoming material and batch release activities; review and approve inspection results and product disposition; lead investigations for low yield and rheology deviations; perform process audits and Gemba walks; develop and coach team members; prepare Certificates of Analysis; trend quality data for continuous improvement.
Seniority
Senior, hands-on IC with people management