Quality Manager, Scientific Operations-Temp
Core
Own quality management across Sample Management and Sample Operations functions, ensuring alignment with company-wide quality standards and regulatory compliance.
Role type
Senior Quality Manager, Scientific Operations
Builds
Quality frameworks, compliance structures, and QA/QC systems for cell-free DNA testing operations
Domain
Biotechnology / Clinical Diagnostics / Cell-free DNA
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAP compliance, GLP/GxP/ISO 9001/17025 frameworks, Root Cause Analysis (RCA), CAPA processes, SOP governance, audit management, LIMS data logging, biobank regulations
Preferred skills
Early-stage startup experience, building QA/QC systems from scratch
Technologies
LIMS, QMS
Responsibilities
Lead Root Cause Analysis (RCA) and CAPA processes for quality deviations; Conduct systematic spot-checks and routine audits of lab run packages and experimental records; Manage the full lifecycle of SOPs, technical protocols, and safety documents; Train Scientific Operations staff on QA/QC expectations and regulatory requirements; Propose and drive continuous improvements to existing quality workflows; Partner with scientific staff to enforce data-logging standards within LIMS
Seniority
Senior, hands-on IC
