Senior Quality Compliance Specialist
Core
Lead specialist compliance programmes and act as Subject Matter Expert for Data Integrity, ISO 13485, and Controlled Drug compliance within a clinical trial supply chain site.
Role type
Senior Quality Compliance Specialist (Technical Lead)
Builds
Inspection-ready quality systems and compliant clinical trial supply chain operations
Domain
Life Sciences / Clinical Trials / Pharmaceutical Manufacturing
Required skills
EU GMP, FDA cGMP, ISO 13485 regulatory knowledge, Data Integrity governance, Controlled Drug compliance, regulatory interpretation, risk management, programme ownership
Preferred skills
Data Integrity principles, Controlled Drug/Home Office licensing, regulatory inspection support
Technologies
GxP systems, validation tools, change management systems
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 cross-functional teams to embed regulatory requirements into processes
Seniority
Senior, hands-on IC with technical leadership
