Supplier Quality Specialist

2 days ago

Dublin, Ireland Cpl 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 assessmentsOwn supplier-related deviations and SCARs, including investigationsSupport quality agreement lifecycle from initiation to coordinationParticipate in internal/supplier audits under QA Auditor guidanceHandle supplier qualification/re-evaluation, risk and quality assessmentsAuthor and revise departmental proceduresAssemble data for Annual Product Quality Review (APQR)Conduct supplier site visits for investigationsLead inspection readiness and employee training initiativesSupport external audits/inspections (FDA, Notified Bodies, etc.)Handle post-inspection follow-ups and documentationPerform other duties as assigned

Required Knowledge, Skills & Abilities

Strong understanding of GMP/cGMP and international regulations:Experience with supplier quality, deviation handling, and change controlProficient in technical writing, communication, collaboration, and trainingAble to work independently and prioritize deadlinesComputer literacy: Microsoft Office Suite (Word, Excel, PowerPoint, etc.)

Core Values Alignment

Candidates must demonstrate alignment with our Core Values:

Centre on PeopleAre Proactive & AgileAct EthicallyConstantly ImproveAre Accountable

Qualifications

Education: Bachelor’s degree in a scientific discipline requiredExperience:3-5 years for Specialist and 6-10 years for Manager role pharmaceutical Quality Assurance/Control rolesExperience with API suppliers highly desirablePreferred: Supplier/raw material management, audit experience, inspection readiness

Working Conditions

Standard schedule: Mon–Fri, 8am–5pm, with flexibility for overtimeUp to 10% travel, including domestic and occasional international

Ideal Candidate Profile

This role suits someone who:

Has a solid foundation in GMP/QMS principlesIs comfortable taking ownership of quality events and supplier relationshipsCan effectively collaborate across technical, QA, and supply chain teamsEnjoys auditing, documentation, and inspection prepBrings a proactive mindset aligned with regulatory excellence and process improvement

#LI-SD1

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