Biotech QA Manager

2 weeks ago


Dublin, Dublin City, Ireland JobContax Full time

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Biotech QA Manager - External Suppliers - Remote, Dublin

Client: JobContax

Location: Dublin, Ireland

Job Category: Other

EU work permit required: Yes

Job Reference:

d8d21bea0d86

Job Views:

10

Posted:

19.08.2025

Expiry Date:

03.10.2025

Job Description:

Biotech QA Manager - External Suppliers - Remote

Employment Type: Contract

Work Location: Remote

Experience: 10+ years

Visa: EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state-of-the-art aseptic manufacturing facility in Dun Laoghaire, South Dublin.

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.

This is an excellent opportunity to gain experience in Ireland's leading aseptic manufacturing plant.

Responsibilities include quality and compliance oversight of contract labs, CMOs, or raw material SREs, aligning with CTA / Marketing Application, and being an integral part of a cross-functional team.

Key duties involve negotiating and approving quality agreements, leading regulatory inspections, reviewing master batch records, approving deviations, change controls, CAPA, preparing inspection playbooks, identifying risks, managing audits, supporting lot release activities, and making batch release decisions.

Requirements include a doctorate with 2 years of related experience, a master's with 4 years, a bachelor's with 6 years, or 10+ years in biotech/pharma. Additional European languages are desirable. Significant experience in aseptic manufacturing quality, stakeholder management, project management, and problem-solving is essential.

The role is fully remote with quarterly on-site visits to Dun Laoghaire and occasional travel within Europe.

Package: Fully remote with quarterly site visits and some travel.

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