We are recruiting a full-time Head of Quality for a pharmaceutical client in Citywest, Dublin. The responsibility for this role spans all divisions within the organisation, including Distribution, Wholesale, and Consumer sectors. The successful candidate will also be nominated as the Responsible Person for the company’s WDA licenses.
Lead Quality Control for Distribution operations, covering Goods Receiving, Medicinal Product Release, and Falsified Medicines Directive compliance.
Oversee Quality Assurance, ensuring compliance with Quality Management System standards, including Documentation, Risk Management, and Validation.
Manage the central Master Data team, maintaining data integrity in various systems.
Handle the disposition of returned, rejected, recalled, or falsified products.
Conduct timely self-inspections and ensure CAPAs are completed according to agreed timelines.
Oversee External Audit programs, including audits of Manufacturers/Vendors and 3rd Party Service providers.
Execute the Validation Master Plan, including Temperature Validation, for company facilities and equipment.
Provide leadership to the Quality and Master Data teams, emphasizing regulatory and business commitments, and ensure resource allocation aligns with business needs.
Proven success in a similar Quality leadership role with a minimum of 5 years of experience in Quality Management.
Formal Certification as Responsible Person and Certified/Experienced Auditor with expertise in Competent Authority inspection programs.
Strong organisational, communication, and problem-solving skills, along with a proactive, influential, and highly self-motivated work ethic.