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 pharmaceutical manufacturing environment.
Role type
Senior IC Quality Control Manager
Builds
Injectable medicines and medical devices
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
cGMP compliance, batch release management, root cause analysis, CAPA implementation, team leadership, inspection plan creation, data trend analysis, process auditing, technology transfer support, SAP proficiency
Preferred skills
Pharmaceutical or medical device manufacturing experience, Six Sigma/A3 methodology, risk-based quality planning, gamma irradiation certificate review, change management
Technologies
SAP, ERP systems
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, rheology deviations, and quality issues; Perform process audits and Gemba walks; Develop and coach team members; Prepare Certificates of Analysis and support technology transfer.
Seniority
Manager, people management & operations