What You’ll Be Doing:· Provide quality compliance leadership for GDP and applicable GMP system processes within the Quality Management System.· Support the Responsible Person and Deputy Responsible Persons in maintaining ongoing compliance with Wholesale Distribution Authorisation requirements and HPRA GDP expectations.· Support oversight of Wholesale Distribution Authorisation requirements, ensuring that authorised activities, site operations, procedures and records remain aligned with HPRA GDP expectations and approved licence scope.· Maintain inspection readiness by ensuring quality processes, records, procedures, training and evidence are complete, current, accurate and readily available for regulatory inspection.· Manage and improve the deviation, investigation and CAPA processes, ensuring timely root cause analysis, effective corrective and preventive actions, appropriate risk assessment and documented effectiveness checks.· Oversee change control activities, including quality impact assessment, regulatory/GDP impact assessment, action tracking and completion verification.· Maintain and improve the document control system, ensuring procedures, forms, records and quality agreements are controlled, approved, reviewed and aligned with current regulatory and business requirements.· Lead or support the internal audit and self-inspection programme across relevant sites, functions and quality systems, ensuring findings are documented, risk assessed and closed effectively.· Manage supplier, customer and service provider qualification processes, including bona fides checks, vendor approval, outsourced activity oversight and periodic review.· Ensure appropriate quality oversight of storage, temperature control, cold chain, transport, returns, quarantine, rejected goods and destruction processes.· Support qualification, mapping, monitoring and periodic review of storage and transportation conditions to ensure medicinal product quality is maintained throughout the supply chain.· Maintain effective training management processes for GDP and applicable GMP activities, including role-based training, training effectiveness and compliance monitoring.· Support quality risk management activities and ensure risks to product quality, patient safety, data integrity and regulatory compliance are appropriately identified, assessed, controlled and reviewed.· Prepare, review and report relevant quality metrics, trends and management review inputs, including deviations, CAPA, complaints, change controls, audits, training, recalls and supplier performance.· Promote a strong quality culture through coaching, clear communication, cross-functional collaboration and proactive resolution of quality issues.What You’ll Need to Succeed:· Minimum of five years’ experience in a team leader or management role within a pharmaceutical quality, wholesale distribution, manufacturing, logistics or regulated healthcare environment.· Previous experience acting as a Responsible Person, Deputy Responsible Person or in a role with delegated RP responsibilities within a wholesale distribution or medicinal product supply chain environment.· Strong working knowledge of HPRA GDP expectations, EU GDP Guidelines, medicinal product wholesale distribution requirements and Quality Management System principles.· Working knowledge of GMP principles relevant to outsourced activities, supplier oversight, product quality defects, secondary packaging interfaces or other applicable regulated activities.

• Quality, Risk and Compliance ManagerCamphill Communities of Ireland (CCoI) supports people with physical/intellectual disabilities and autism. CCoI operates Residential and Day Services across 15 locations, in which residents and day-attendees are supported to live an ordinary life, a life like any other.We are currently recruiting for a Quality, Risk and Compliance Manager to join our National team.Contract: PermanentHours: Fulltime (40 hours per week)Salary: €58,087 - €77,599 per annumLocation: Dunshane, Naas Co Kildare, with travel to the various locationsYou will have the opportunity to work as part of a committed team, we offer a competitive salary, and you will have access to collaborative and learning work within a leading national organisation.What you will need:· Hold a minimum of a Level 7 Degree on the QQI Framework - BA in Social Care Studies, Social Care Work, Health, ID Nursing or equivalent relevant qualification in a relevant professional discipline· Candidates with a post graduate qualification in Quality Management will be viewed with a distinct advantage· 3-5 years experience in a compliance management role