Analytical Quality Lead for External Manufacturing & CMOs

PE Global; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

PE Global is seeking an Analytical Quality Specialist for a multinational biopharma client in Dublin. The role supports analytical testing across RSM, Intermediate, API and Drug Product manufacturing at CMOs/CTLs and liaises with global QA teams.

You will drive investigations, change controls and data integrity within an external manufacturing ecosystem. The ideal candidate has 3–5 years in GMP QC, strong knowledge of GMP requirements (FDA/EU), and proven experience in QC labs and regulatory

Qualifications

• Minimum B.A. or B.Sc. in life sciences.
• 3-5 years’ experience in GMP QC environment.
• Thorough knowledge of worldwide regulatory GMP requirements (FDA/EU).
• Experience in QC laboratory operations and deviation handling.
• Familiarity with electronic document and deviation management systems.

Responsibilities

• Provide analytical expertise and troubleshooting for external manufacturing environments.
• Coordinate testing of Pharma products at CMOs and CTLs; manage testing plans with stakeholders.
• Act as analytical contact for CMOs/CTLs and oversee investigations, OOS events, and change controls.
• Review and approve laboratory investigations and deviations in partnership with SMEs and QP/RP.
• Lead major analytical investigations and manage data records; support regulatory submissions and audits.

Skills

GMP QC

Analytical testing

Change controls

Audits

Documentation

Laboratory troubleshooting

Education

B.A./B.Sc. in life sciences

Job description

PE Global is seeking an Analytical Quality Specialist for a multinational biopharma client in Dublin. The role supports analytical testing across RSM, Intermediate, API and Drug Product manufacturing at CMOs/CTLs and liaises with global QA teams.

You will drive investigations, change controls and data integrity within an external manufacturing ecosystem. The ideal candidate has 3–5 years in GMP QC, strong knowledge of GMP requirements (FDA/EU), and proven experience in QC labs and regulatory