Senior Specialist, External Manufacturing Quality (Analytical)

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

Senior Specialist, External Manufacturing Quality (Analytical)

Global biopharmaceutical company

Dublin

12-month PAYE contract

December 2026

€32 per hour

A 12-month analytical quality contract with a global biopharmaceutical company in Dublin,

overseeing testing at contract manufacturers and contract labs.

About the role

Our client makes a large share of its products through external partners. This role is the analytical quality lead

for that network, covering testing of regulatory starting materials (RSM), intermediates, active pharmaceutical

ingredients (API) and drug product.

You will be the main analytical contact for contract manufacturing organisations (CMOs) and contract testing

laboratories (CTLs). You will work within Virtual Plant Teams: cross-functional teams that manage each

externally made product as if it were made in-house.

It suits a QC laboratory specialist who wants to move into a broader quality oversight role, working with third

parties and global functions.

What you'll do

Analytical oversight of CMOs and CTLs

• Provide analytical expertise and troubleshooting support across the external manufacturing network.
• Plan and manage product testing at CMOs and CTLs with internal and external stakeholders.
• Act as the analytical contact for CMOs and CTLs, resolving issues and requests with the right teams.
• Prepare sample submission forms and track shipment, receipt, testing and release status.
• Make sure reference standards and critical reagents are supplied on time.
• Review and approve lab investigations, deviations and out-of-specification (OOS) results at CMOs and CTLs, with method experts.
• Give technical support to the Qualified Person (QP) and Quality Operations on these events.
• Lead investigations for major analytical deviations in the electronic quality system.
• Review and approve analytical change controls from CMOs and CTLs, and assess the impact of internal changes on external testing.
• Raise internal change controls for analytical changes affecting CMOs and CTLs. Methods, transfers and stability
• Coordinate communication between CMO/CTL analytical teams and global functions, including testin standards, reference standards, QC strategy and microbiology.
• Manage method and specification updates to CMOs and CTLs.
• Support analytical technical transfers to CMOs and CTLs.
• Review method validation, transfer and verification against ICH guidelines, and manage gap remediation.
• Work with the global stability team and Virtual Plant Teams on CMO stability programmes.

Wider quality support

• Support internal and external audits as the QC laboratory subject matter expert.
• Support review of sample plans, Annual Product Quality Reviews (APQRs), risk assessments and quality agreements.
• Coordinate data requests from CMOs and CTLs.
• Assist with analytical sections of regulatory submissions.
• Support Procurement with requests for proposal (RFPs) for testing services.

What you'll bring

• A degree (BA or BSc minimum) in a life science.
• 3 to 5 years’ experience in a GMP QC environment, ideally in a pharmaceutical QC laboratory.
• Testing experience across RSM, intermediates, API and drug product.
• Thorough knowledge of global GMP requirements, with working knowledge of FDA and EU GMP.
• In-depth knowledge of quality management systems for laboratory operations.
• The ability to critique analytical investigation reports objectively.
• Proven troubleshooting and project management skills.
• Confidence working independently and in a matrix team.
• Experience with electronic document and deviation management systems.
• Working knowledge of analytical technical transfers.
• Experience managing third-party relationships, such as CMOs or contract labs.