Supplier Quality

1 week ago

Dublin, Ireland CPL Full time

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.

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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)

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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

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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.)

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Core Values Alignment

Candidates must demonstrate alignment with our Core Values:

1. Centre on People
2. Are Proactive & Agile
3. Act Ethically
4. Constantly Improve
5. Are Accountable

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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

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Working Conditions

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

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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

#LI-SD1

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