Quality Assurance Compliance Manager
Core
Lead the development and maintenance of the quality system to ensure compliance with regulatory requirements and GMP for pharmaceutical manufacturing.
Role type
Senior IC Quality Assurance Compliance Manager
Builds
Pharmaceutical manufacturing site quality systems and compliance programs
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
GMP compliance, CAPA management, Change Management, Document Management, Inspection readiness, Supplier management, Team leadership, Regulatory liaison, Continuous improvement, AI-enabled tools adoption
Preferred skills
Qualified Person (QP) eligibility, Veeva Vault, TrackWise, ComplianceWire
Technologies
Veeva Vault, TrackWise, ComplianceWire, Microsoft Office
Responsibilities
Lead QA aspects of the site quality system including CAPA, Change Management, and Inspection Readiness; Develop and manage the quality system to ensure compliance with FDA, ICH, and EudraLex requirements; Prepare and maintain the Site Master File and Quality Manual; Liaise with regulatory bodies like FDA and HPRA; Lead regulatory inspection and corporate audit preparation; Lead, manage, and develop quality professionals within the QA Compliance group.
Seniority
Senior, hands-on IC with people management responsibilities
