QA Regulatory Compliance Specialist
Core
Implement and execute tasks for the introduction and maintenance of Clinical products within the RCT department, supporting QP release and regulatory oversight.
Role type
QA Regulatory Compliance Specialist
Builds
Clinical supply chain products and quality systems for biopharma clients
Domain
Biopharmaceuticals / Clinical Supply Chain / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EU regulatory requirements knowledge, GMP regulations application, FDA guidelines application, Quality Systems management, Supplier qualification, Deviation management, SOP creation, Client facing experience
Preferred skills
External supplier auditing, Regulatory filings
Technologies
Master Control system
Responsibilities
Create and maintain Product Specification File (PSF) for Clinical supply chain, Manage Quality Systems & Compliance for third-party supply chains, Maintain Approved CMO list, Ensure compliance with customer and regulatory requirements, Manage Supplier Management Programme including audits and technical agreements, Prepare QP declarations, Support Manufacturing and Importation Licence management, Raise Deviations and Non-Conformance reports, Generate SOPs and Work Instructions, Identify process improvement opportunities
Seniority
Mid-level, hands-on IC
