Senior Quality Compliance Specialist
Core
Lead specialist compliance programmes and act as the Subject Matter Expert for Data Integrity, ISO 13485, and Controlled Drug compliance within a Clinical Trials Division site.
Role type
Senior Quality Compliance Specialist (Technical Lead)
Builds
Inspection-ready quality systems and compliant clinical supply chain operations
Domain
Pharmaceutical/Biotechnology / Clinical Trials / GxP
Required skills
EU GMP, FDA cGMP, ISO 13485, Data Integrity, Controlled Drug compliance, Regulatory interpretation, Risk management, Programme ownership
Preferred skills
Data Integrity governance, Controlled Drug/Home Office licensing, Regulatory inspection support
Technologies
GxP systems, Validation tools
Responsibilities
Lead specialist compliance programmes supporting EU GMP, FDA cGMP, and ISO 13485; Lead the site's Data Integrity Programme and risk assessments; Act as Subject Matter Expert during regulatory inspections and audits; Coordinate implementation of compliance projects; Partner with process owners to strengthen regulatory governance.
Seniority
Senior, hands-on IC with technical leadership