Supplier Quality Specialist & Manager My client, an international pharma company specialising in Oncology and Endocrinology, is growing their team in Dublin and is now seeking a talented Supplier Quality (Senior) Specialist and a Manager.
Work with a company who are 'Family First' and offer flexibility, remote working and a close knit, inclusive team.
1 day per week in the office in Dublin city centre, with flexibility around business needs.
Purpose & Scope This role is primarily responsible for overseeing supplier quality processes including change control, quality agreements, supplier audits, and inspection readinessfocusing on Contract Manufacturing / Packaging Organizations (CMOs / CPOs) Key Responsibilities Manage Supplier Change Notification Program and perform impact assessments Own supplier-related deviations and SCARs, including investigations Support quality agreement lifecycle from initiation to coordination Participate in internal / supplier audits under QA Auditor guidance Handle supplier qualification / re-evaluation, risk and quality assessments Author and revise departmental procedures Assemble data for Annual Product Quality Review (APQR) Conduct supplier site visits for investigations Lead inspection readiness and employee training initiatives Support external audits / inspections (FDA, Notified Bodies, etc.) Handle post-inspection follow-ups and documentation Perform other duties as assigned Required Knowledge, Skills & Abilities Strong understanding of GMP / cGMP and international regulations : Experience with supplier quality, deviation handling, and change control Proficient in technical writing, communication, collaboration, and training Able to work independently and prioritize deadlines Computer literacy : Microsoft Office Suite (Word, Excel, PowerPoint, etc.) Core Values Alignment Candidates must demonstrate alignment with our Core Values : Centre on People Are Proactive & Agile Act Ethically Constantly Improve Are Accountable Qualifications Education : Bachelors degree in a scientific discipline required Experience : 3-5 years for Specialist and 6-10 years for Manager role pharmaceutical Quality Assurance / Control roles Experience with API suppliers highly desirable Preferred : Supplier / raw material management, audit experience, inspection readiness Working Conditions Standard schedule : MonFri, 8am5pm, with flexibility for overtime Up to 10% travel, including domestic and occasional international Ideal Candidate Profile This role suits someone who : Has a solid foundation in GMP / QMS principles Is comfortable taking ownership of quality events and supplier relationships Can effectively collaborate across technical, QA, and supply chain teams Enjoys auditing, documentation, and inspection prep Brings a proactive mindset aligned with regulatory excellence and process improvement #LI-SD1
Quality Manager • Ireland