Supervisor - Quality Assurance
Core
Oversee Deviation, CAPA, and Change Control programs to ensure regulatory compliance and quality standards in biologics manufacturing.
Role type
Supervisor, Quality Assurance (QA)
Builds
Biologics drug substances and cell lines for clinical production
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Deviation management, CAPA management, Change Control, Root cause analysis, Risk assessment, Regulatory compliance, Quality systems expertise, Team leadership, Audit support
Preferred skills
Trackwise system knowledge, Managing direct reports
Technologies
Trackwise
Responsibilities
Lead and oversee Deviation, CAPA, and Change Control programs; Manage the full lifecycle of investigations and effectiveness checks; Serve as Subject Matter Expert for Quality Systems; Monitor quality metrics and drive process improvements; Support regulatory inspections and internal audits
Seniority
Supervisor, 0-2 years leadership experience