Senior Specialist, QA Compliance
Core
Senior Specialist supporting the development, implementation, and operation of site compliance programmes including Data Integrity, Quality Agreements, and Artificial Intelligence Governance for a biologics manufacturing site.
Role type
Senior Specialist, QA Compliance (Biologics Manufacturing)
Builds
Data Integrity Master Plan, AI Governance Programme, Quality Agreements, and compliance culture
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models
Required skills
Data Integrity, AI Governance, Quality Agreements, Supplier Qualification, Internal Audits, Health Authority Inspections, Quality Systems (Deviations, CAPAs, Change Controls), GMP
Preferred skills
Pharmaceutical Quality Systems, Risk-Based Decision Making, Cross-functional Collaboration
Technologies
None stated
Responsibilities
Develop and maintain Data Integrity and AI Governance programmes; Review and approve Data Integrity Risk Assessments; Draft and approve Quality Agreements with suppliers; Participate in internal audits and support Health Authority inspections; Support supplier qualification and oversight activities; Author and approve QA procedures and controlled documentation.
Seniority
Senior, hands-on IC