Senior Scientist, QC Compliance
Core
Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs, and change controls while ensuring compliant closure and representing the department in inspections.
Role type
Senior Scientist, QC Compliance
Builds
Quality management systems and regulatory compliance documentation for biopharmaceutical operations
Domain
Biopharmaceuticals / Quality Control / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, regulatory compliance (cGMP), technical writing, KPI generation, CAPA effectiveness analysis, document revision, change management, mentoring
Preferred skills
Analytical testing, microbiological testing, laboratory investigations, biomanufacturing investigations
Technologies
Quality management systems
Responsibilities
Lead and author QC deviations, laboratory investigations, CAPAs, and change controls; conduct root cause analysis on complex non-routine investigations; generate and report KPIs; represent department in internal/external inspections; train and mentor others on compliance processes
Seniority
Senior, hands-on IC
