Supplier Quality Specialist

3 weeks ago

Dublin Pike, Ireland Cpl Healthcare Full time

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 readiness—focusing 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:
Bachelor’s 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: Mon–Fri, 8am–5pm , 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
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