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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/c GMP 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, Power Point, 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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