Senior Quality Compliance Manager
3 days ago
Transform patient lives through innovation at Talent Works.
Job DescriptionWe are seeking an Associate Director, Responsible Person (Ireland) to lead quality compliance and Good Distribution Practice (GDP) initiatives for our Ireland Affiliate.
- Ensure compliance with GDP and GxP standards while overseeing the distribution network and driving strategic quality assurance (QA) initiatives.
- Represent the company in regulatory inspections and support wider regional and global quality projects.
Quality Compliance: Act as the Responsible Person (RP) on Wholesale Distribution Authorisation (WDA), ensuring full compliance with HPRA and EU GDP guidelines.
Quality Management System (QMS): Lead QMS implementation and maintenance, ensuring best practices are upheld.
Distribution Network Improvement: Drive quality initiatives related to distribution network improvements.
Regulatory Inspections and Compliance: Manage regulatory inspections, audits, and compliance activities, including CAPA implementation and engagement with Health Authorities.
GDP-Related Activities: Approve GDP-related activities such as supplier and customer qualifications, subcontracting approvals, and product recalls.
Training and Development: Ensure continuous training and development for GDP-related activities.
Risk Management: Oversee risk management activities and support decision-making on product quality matters.
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