Pharma Quality Specialist Consultant
Core
Lead the design, transformation, and implementation of GxP-compliant Quality Management Systems (QMS) for pharmaceutical and biotechnology clients, covering R&D, manufacturing, and clinical environments.
Role type
Senior IC Pharma Quality Specialist Consultant
Builds
GxP-compliant QMS frameworks, validation strategies, regulatory documentation, and supplier qualification programs
Domain
Life Sciences / Pharmaceutical Quality / Regulatory Compliance
Required skills
GxP regulatory frameworks (GMP, GDP, GCP, GLP), QMS design and transformation, Computer System Validation (CSV), supplier qualification and audit management, CAPA development, RIM/PLM system implementation, change management
Preferred skills
Management Consultancy experience, Qualified Person (QP) status, ISO 13485 knowledge, combination product environment experience
Technologies
RIM systems, PLM systems, GxP QMS platforms
Responsibilities
Lead QMS design and process transformation across diverse client engagements; Conduct gap assessments and author quality policies/SOPs; Advise on CSV activities and data integrity controls; Support supplier audits and CAPA initiatives; Implement Regulatory Information Management (RIM) systems; Act as or support a Qualified Person (QP) for product release
Seniority
Senior, hands-on IC
