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
* 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 across technical, QA, and supply chain teams
* Enjoys auditing, documentation, and inspection prep
* Brings a proactive mindset aligned with regulatory excellence and process improvement