Senior QA Specialist - Batch Release & Compliance

Summittherapeutics; Ireland; On-site; EUR 90,000 - 120,000; Full time

Job summary

Summit Therapeutics is seeking a Senior Specialist, QA to lead the QA activities for review, approval and release-readiness of clinical and commercial product batches. The role ensures complete, traceable and GMP-compliant batch documentation prior to QA disposition or QP certification.

You will coordinate batch-release activities across Quality, Manufacturing, Supply Chain, Regulatory Affairs and external CMOs, driving process improvements and data integrity across the batch-release process.

Qualifications

• Qualification in Quality, Pharmaceutical Science, Life Sciences, Engineering or related discipline.
• Significant QA experience in a regulated pharma or biopharma environment (biologics preferred).
• Experience reviewing batch records and supporting batch disposition or QP certification.
• Knowledge of GMP, Good Documentation Practice and data-integrity requirements.
• Experience with deviations, investigations, CAPAs and change controls.
• Experience with electronic quality systems (MasterControl, Veeva Vault, TrackWise, SAP or equivalent).
• Ability to coordinate priorities and meet release timelines.
• Experience supporting release of medicinal products or IMPs.

Responsibilities

• Provide day-to-day QA leadership for batch review and release readiness.
• Coordinate QA review of batch manufacturing, packaging, testing and release documentation.
• Prepare and collate documents for final batch disposition or QP certification.
• Verify batch records for completeness, accuracy and GMP compliance.
• Assess and approve deviations, investigations, CAPAs and lab results before release.
• Identify documentation gaps and coordinate timely resolutions.
• Maintain batch-release priorities, track release dates and escalation paths.
• Support inspection readiness and continuous improvement in QA processes.
• Collaborate with Manufacturing, Regulatory, Supply Chain and external partners to ensure timely release.

Skills

QA

GMP

Documentation

Batch release

CAPA

Deviations

Leadership

Education

Quality/Pharma degree

Tools

MasterControl

Veeva Vault

TrackWise

SAP

Job description

Summit Therapeutics is seeking a Senior Specialist, QA to lead the QA activities for review, approval and release-readiness of clinical and commercial product batches. The role ensures complete, traceable and GMP-compliant batch documentation prior to QA disposition or QP certification.

You will coordinate batch-release activities across Quality, Manufacturing, Supply Chain, Regulatory Affairs and external CMOs, driving process improvements and data integrity across the batch-release process.