Supplier Quality (Senior) Specialist
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
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