Senior Specialist, QA
Core
Provide operational leadership and quality oversight for the review, approval, and release-readiness of clinical and commercial product batches.
Role type
Senior Specialist, QA (Batch Release)
Builds
Clinical and commercial biological product batches for oncology studies
Domain
Biopharmaceuticals / Oncology / GMP
Required skills
Batch documentation review, GMP compliance, Deviation management, CAPA coordination, Change control assessment, Stakeholder coordination, Data integrity oversight, Inspection readiness, Process improvement, Risk identification
Responsibilities
Coordinate end-to-end QA review of executed batch manufacturing, packaging, testing, and release documentation for IMP and Commercial biological batch records; Prepare and collate batch documentation required for final batch disposition or QP certification from internal and external sources; Verify that batch records are complete, accurate, and compliant with approved procedures, specifications, and applicable GMP requirements; Confirm that relevant deviations, investigations, change controls, CAPAs, and laboratory results have been appropriately assessed and approved before release; Identify documentation gaps, discrepancies, and potential compliance risks, and coordinate their timely resolution; Maintain oversight of batch-release priorities, review status, outstanding actions, and planned release dates; Escalate critical issues or potential delays to Quality leadership and relevant stakeholders.