Quality Compliance Manager / Responsible Person

Job Title: Quality Compliance Manager / Responsible Person

Industry: Pharmaceuticals

Location: Ballycoolin, Dublin

Type: Full-Time, Permanent

About Us

Our organization specializes in reproductive sciences, dedicated to empowering individuals and families in their parenthood journey. As a proud member of the ReproMed Group, we uphold a legacy of leadership and innovation in reproductive medicine. Committed to research-driven solutions and patient-centric care, we aim to redefine global standards in reproductive healthcare.

Job Summary

The Quality & Compliance Manager, serving as the Responsible Person (RP), will focus on advancing Quality Management Systems and ensuring compliance with relevant standards and regulations.

Responsibilities

Quality:

• Conduct QA inspections of deliveries, ensuring compliance with GDP.
• Validate and oversee in-house and outsourced temperature management systems.
• Manage WDA/GDP requirements and serve as the Responsible Person.
• Implement self-inspection and internal audit protocols.
• Oversee international bona fides, due diligence, and license verifications.
• Maintain Quality filing, recording, and documentation.
• Develop and monitor training programs for GDP personnel.
• Engage with regulators and participate in relevant training programs.

Compliance:

• Initiate and manage investigations, including CAPA, Deviation, Recall, and Returns.
• Qualify Medicinal Product Sourcing through product authenticity validation.
• Review databases for license information and engage with Competent Authorities.
• Develop and approve falsified medicines verification systems.
• Lead ongoing development of QMS for the Medical Device Division.
• Process applications as Medical Device Importer, Distributor & Authorized Representative.

Qualifications:

• Degree in Pharmacy, Chemistry, Microbiology, or Engineering.
• PMI membership desirable.
• Three years' practical experience in handling, storage, and distribution of medicinal products.
• One year's managerial experience in wholesale distribution.
• Experience in implementing Quality Management Systems.

Salary:

€70,000 - €80,000 per annum

How to Apply:

Submit your CV to (url removed) with "Quality Compliance Manager / Responsible Person" in the subject line.