Quality Manager
Core
Lead Quality Control and Quality Assurance organizations to ensure compliance, drive continuous improvement, and manage QC laboratory operations in the pharmaceutical/biotech industry.
Role type
Senior Quality Manager (Regulated Pharma/Biotech)
Builds
Robust QA systems and compliant QC laboratory operations
Domain
Pharmaceutical/Biotech manufacturing and quality assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
People management, cGMP regulations knowledge, analytical testing methods, LIMS, root cause analysis, risk-based approach, audit leadership, policy development, performance management
Preferred skills
Chemistry/Biology background, continuous improvement methodologies, stakeholder engagement, strategic problem solving
Technologies
LIMS, FMEA, Risk Analysis tools
Responsibilities
Translate site objectives into actionable quality plans, lead external regulatory inspections and customer audits, oversee internal audit programs, manage nonconforming material investigations, develop quality talent through coaching and succession planning, recommend updates to QC/QA policies and procedures, monitor quality performance metrics and drive corrective actions
Seniority
Senior, hands-on IC with people management