(Senior) QA Expert Compliance 80-100%
Core
Lead and maintain Quality Management Systems (QMS) and ensure GMP compliance for sterile pharmaceutical manufacturing operations.
Role type
Senior QA Expert Compliance (GMP)
Builds
Quality Management Systems, compliance documentation, and regulatory readiness for drug product services.
Domain
Pharmaceutical manufacturing (sterile), Quality Assurance, Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, QMS development and maintenance, deviation and CAPA management, change control, document management, regulatory inspection representation, cross-functional collaboration
Preferred skills
TrackWise, MasterControl, DMS, Cornerstone, Veeva, sterile manufacturing experience, PhD in scientific field
Technologies
TrackWise, MasterControl, DMS, Cornerstone, Veeva
Responsibilities
Lead QMS development and maintenance per cGMP/ISO; Act as SME for compliance topics and provide training; Manage and investigate deviations, CAPAs, and change controls; Review and approve quality documentation (SOPs); Prepare compliance reports and metrics; Represent company during regulatory inspections and audits; Collaborate cross-functionally to embed quality in product lifecycle
Seniority
Senior, hands-on IC
