Analytical Quality Lead, External Manufacturing

Next Generation; Dublin; On-site; EUR 37,000 - 51,000; Full time

Job summary

Next Generation is seeking a Senior Specialist, External Manufacturing Quality (Analytical) in Dublin to oversee analytical testing at CMOs/CTLs within global product networks. The role sits in a 12-month PAYE contract, focusing on RSM, intermediates, API and drug product testing, with emphasis on regulatory compliance and QMS oversight.

You will be the main analytical contact for CMOs/CTLs, coordinating testing plans, deviations and change controls, and supporting QP and Quality Operations on

Qualifications

• Degree in life science (BA or BSc) required.
• 3–5 years GMP QC experience in pharma.
• Experience with testing across RSM, intermediates, API and drug product.
• Knowledge of FDA/EU GMP and global GMP.
• Experience managing third-party CMOs/CTLs.

Responsibilities

• Provide analytical expertise across external manufacturing network.
• Plan and manage product testing at CMOs and CTLs.
• Act as analytical contact for CMOs and CTLs; resolve issues.
• Prepare submission forms; track shipment, testing and release status.
• Review lab investigations and OOS results at CMOs/CTLs.
• Lead investigations for major analytical deviations.
• Support analytical transfers to CMOs/CTLs.
• Review method validation/transfer against ICH; manage gaps.
• Coordinate communication between CMO/CTL teams and global functions.

Skills

GMP QC

Analytical testing

Project management

Independent work

Vendor management

Education

BA or BSc in life science

Tools

Electronic document management

Deviation management systems

Job description

Next Generation is seeking a Senior Specialist, External Manufacturing Quality (Analytical) in Dublin to oversee analytical testing at CMOs/CTLs within global product networks. The role sits in a 12-month PAYE contract, focusing on RSM, intermediates, API and drug product testing, with emphasis on regulatory compliance and QMS oversight.

You will be the main analytical contact for CMOs/CTLs, coordinating testing plans, deviations and change controls, and supporting QP and Quality Operations on