Lead - Biomanufacturing Compliance - Investigator, Deviations
Core
Lead investigator for biomanufacturing deviations, authoring records, leading root cause analysis, and driving inspection readiness for biologics manufacturing.
Role type
Senior IC biomanufacturing compliance investigator
Builds
Compliant biologics drug substance production
Domain
Biopharmaceuticals / Biologics manufacturing
Required skills
Deviation investigation, Root Cause Analysis, CAPA implementation, cGMP principles, SOP authoring, Quality systems proficiency, Manufacturing operations knowledge, Audit support, Process improvement
Preferred skills
Large-scale upstream/downstream biological manufacturing experience
Technologies
TrackWise, ComplianceWire, JD Edwards, Unicorn
Responsibilities
Author and revise complex deviation records and cGMP documents; Lead initiatives to improve process compliance culture; Lead Inspection Readiness activities and teams; Write and revise Standard Operating Procedures; Provide support to internal and client audits regarding deviations and CAPA
Seniority
Senior, hands-on IC