Senior Quality Engineer
Core
Provide technical quality oversight throughout the product lifecycle for biotechnology and life sciences products, ensuring regulatory compliance and operational excellence.
Role type
Senior Quality Engineer (Regulated Life Sciences)
Builds
GMP-compliant laboratory and manufacturing operations
Domain
Biotechnology / Life Sciences / Regulated Manufacturing
Required skills
Quality Engineering, cGMP, FDA 21 CFR Parts 210/211/11, ICH Guidelines (Q8/Q9/Q10), Quality Risk Management (QRM), Statistical Process Control (SPC), Process Validation (IQ/OQ/PQ), Root Cause Analysis (5 Why, Fishbone), CAPA, Change Control, Data Integrity (ALCOA+), FMEA, Lean, Six Sigma
Preferred skills
Master's degree, 8+ years experience, Design of Experiments (DOE), Supplier Quality Management
Technologies
QMS, SPC software, Validation Lifecycle Management tools
Responsibilities
Review and release batch records and manufacturing documentation; Lead qualification and validation activities (equipment and process); Apply QbD and statistical analysis to improve process capability; Lead quality investigations and drive CAPA implementation; Support internal and external audits and inspection readiness; Partner with cross-functional teams to resolve quality issues and standardize processes.
Seniority
Senior, hands-on IC