Supplier Quality (Senior) Specialist
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.
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 readiness—focusing on Contract Manufacturing/Packaging Organizations (CMOs/CPOs)
Key Responsibilities
1. Manage Supplier Change Notification Program and perform impact assessments
2. Own supplier-related deviations and SCARs, including investigations
3. Support quality agreement lifecycle from initiation to coordination
4. Participate in internal/supplier audits under QA Auditor guidance
5. Handle supplier qualification/re-evaluation, risk and quality assessments
6. Author and revise departmental procedures
7. Assemble data for Annual Product Quality Review (APQR)
8. Conduct supplier site visits for investigations
9. Lead inspection readiness and employee training initiatives
10. Support external audits/inspections (FDA, Notified Bodies, etc.)
11. Handle post-inspection follow-ups and documentation
12. Perform other duties as assigned
Required Knowledge, Skills & Abilities
13. Strong understanding of GMP/cGMP and international regulations:
14. Experience with supplier quality, deviation handling, and change control
15. Proficient in technical writing, communication, collaboration, and training
16. Able to work independently and prioritize deadlines
17. Computer literacy: Microsoft Office Suite (Word, Excel, PowerPoint, etc.)
Core Values Alignment
Candidates must demonstrate alignment with our Core Values:
18. Centre on People
19. Are Proactive & Agile
20. Act Ethically
21. Constantly Improve
22. Are Accountable
Qualifications
23. Education:
24. Bachelor's degree in a scientific discipline required
25. Experience:3-5 years for Specialist and 6-10 years for Manager role pharmaceutical Quality Assurance/Control roles
26. Experience with API suppliers highly desirable
27. Preferred: Supplier/raw material management, audit experience, inspection readiness
Working Conditions
28. Standard schedule: Mon–Fri, 8am–5pm, with flexibility for overtime
29. Up to 10% travel, including domestic and occasional international
Ideal Candidate Profile
This role suits someone who:
30. Has a solid foundation in GMP/QMS principles
31. Is comfortable taking ownership of quality events and supplier relationships
32. Can effectively across technical, QA, and supply chain teams
33. Enjoys auditing, documentation, and inspection prep
34. Brings a proactive mindset aligned with regulatory excellence and process improvement
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