Senior QA Specialist, Batch Release - Biologic Pharma

Summit Therapeutics; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Summit Therapeutics seeks a Senior Specialist, QA to lead batch-review readiness for clinical and commercial product batches in a fast-paced biopharma environment. You will ensure that batch documentation is complete, accurate, traceable, and compliant with GMP requirements before QA disposition.

The role coordinates QA review with Manufacturing, Regulatory Affairs and external partners, driving timely release and continuous improvement in documentation controls.

Qualifications

• Essential: degree in Quality/Pharmaceutical Science or related field.
• Significant experience in QA within regulated pharma/biotech manufacturing.
• Experience reviewing batch records and supporting batch disposition.

Responsibilities

• Coordinate end-to-end QA review of batch manufacturing, packaging, testing and release documentation for IMP and Commercial batches.
• Maintain oversight of batch-release priorities and release dates; escalate risks as needed.
• Support inspections readiness, deviations, CAPAs and change controls within QA.
• Provide leadership and training to QA reviewers, promote data integrity and Good Documentation Practice.

Skills

Quality Assurance

GMP knowledge

Data integrity

Documentation control

Batch release

Leadership

Education

Quality/Pharmaceutical Science degree

Tools

MasterControl

Veeva Vault

TrackWise

NetSuite

SAP

Job description

Summit Therapeutics seeks a Senior Specialist, QA to lead batch-review readiness for clinical and commercial product batches in a fast-paced biopharma environment. You will ensure that batch documentation is complete, accurate, traceable, and compliant with GMP requirements before QA disposition.

The role coordinates QA review with Manufacturing, Regulatory Affairs and external partners, driving timely release and continuous improvement in documentation controls.