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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 that is 'Family First' and offers 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
* Centre on People
* Proactive & Agile
* Act Ethically
* Constantly Improve
* Accountable
Qualifications
* Education: Bachelor’s degree in a scientific discipline required.
* Experience: 3‑5 years for Specialist and 6‑10 years for Manager role in pharmaceutical Quality Assurance/Control.
* Experience with API suppliers highly desirable.
* Preferred: Supplier/raw material management, audit experience, inspection readiness.
Working Conditions
* Standard schedule: Mon–Fri, 8 am–5 pm, with flexibility for overtime.
* Up to 10% travel, including domestic and occasional international.
Ideal Candidate Profile
* Has a solid foundation in GMP/QMS principles.
* Is comfortable taking ownership of quality events and supplier relationships.
* Can work effectively with technical, QA, and supply chain teams.
* Enjoys auditing, documentation, and inspection preparation.
* Brings a proactive mindset aligned with regulatory excellence and process improvement.
Seniority level
* Mid‑Senior level
Employment type
* Full‑time
Job function
* Quality Assurance
Industries
* Staffing and Recruiting
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