Pharma Quality Specialist Consultant
Core
Design, transform, and implement GxP-compliant Quality Management Systems (QMS) for pharmaceutical and biotechnology clients, covering R&D, manufacturing, clinical, and distribution environments.
Role type
Senior Pharma Quality Specialist Consultant
Builds
GxP-compliant QMS frameworks, validation strategies, regulatory documentation, and system implementations (RIM/PLM)
Domain
Life Sciences / Pharmaceutical Quality / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP QMS design and implementation, Computer System Validation (CSV), Supplier qualification and audit management, Regulatory Information Management (RIM) systems, Product Lifecycle Management (PLM) systems, Global GxP regulatory frameworks knowledge, Change management, CAPA development
Preferred skills
Management Consultancy experience, Qualified Person (QP) status, ISO 13485 knowledge, Combination product environment experience
Technologies
RIM systems, PLM systems, GxP regulatory databases
Responsibilities
Lead QMS design and process transformation across diverse client engagements, Conduct gap assessments and author quality policies/SOPs, Lead CSV activities and data integrity controls, Support supplier audits and CAPA initiatives, Implement and optimize Regulatory and Product Lifecycle Management systems, Act as subject matter expert for inspection readiness and QP support
Seniority
Senior, hands-on IC