Senior Specialist, QA Compliance
Core
Senior Specialist ensuring data integrity, AI governance, and supplier quality compliance for biologics manufacturing operations.
Role type
Senior Specialist, QA Compliance (Biologics)
Builds
Data Integrity Master Plan, AI Governance Programme, Supplier Quality Agreements
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models
Required skills
Data Integrity, AI Governance, Supplier Qualification, Quality Agreements, GMP, Deviations, Investigations, CAPA, Change Controls, Quality Risk Management, SOPs
Preferred skills
Pharmaceutical Quality Systems, Cross-functional collaboration, Continuous improvement
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; Support internal audits and Health Authority inspections; Review quality system documentation (deviations, CAPAs, change controls, risk assessments, SOPs); Support supplier qualification and audits.
Seniority
Senior, hands-on IC
