Quality Improvement Lead
Core
Drive operational quality performance and manufacturing reliability across a life sciences site to ensure right-first-time execution and protect product quality.
Role type
Quality Improvement Lead (Manufacturing)
Builds
Manufacturing processes and quality systems for life-saving diagnostics, vaccines, medicines, and cell/gene therapies.
Domain
Life sciences / Biotechnology / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis (RCA, 5Why, Fishbone, FMEA), Statistical Process Control (SPC), Capability analysis, Pareto analysis, Trend analysis, Cost of Quality reduction, Process control design, Standard work implementation, Stakeholder alignment, ISO/cGMP compliance management
Preferred skills
Lean / DBS / Six Sigma certification, Audit/inspection support (ISO, FDA, MHRA), New product introduction support, Process change management, Equipment/method improvement
Technologies
SPC, RCA, 5Why, Fishbone, FMEA, DBS
Responsibilities
Deliver targeted quality initiatives to improve reliability and right-first-time performance; Partner with stakeholders to identify quality issues and execute practical improvements; Track and trend nonconformances and customer complaints to reduce recurrence; Apply data and quality tools to quantify performance and confirm root causes; Own initiatives to reduce Cost of Quality by strengthening process controls and embedding standard work
Seniority
Mid-Senior, hands-on IC