Senior Drug Product QA Specialist: GMP Oversight & Release

Cytokinetics; Dublin; On-site; EUR 78,000 - 98,000; Full time

Job summary

Cytokinetics is seeking a QA Specialist for Drug Product to oversee QA certification activities across CMOs, ensuring cGMP compliance for clinical and commercial manufacturing. You will review batch records, deviations and change controls, and support regulatory readiness.

You will collaborate with Regulatory, Technical Operations and Supply Chain to ensure product quality and smooth lifecycle management while maintaining a robust quality system in a fast-paced biopharma environment.

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline.
• Minimum 5 years in biopharma/pharma with at least 3 years in GMP QA.
• Experience supporting clinical and/or commercial manufacturing.

Responsibilities

• Provide GMP QA oversight for clinical and commercial manufacturing, packaging, labelling and distribution at CMOs.
• Review GMP batch documentation to support disposition and release.
• Approve deviations, investigations, CAPAs, change controls and QMS records.
• Support technology transfers, process validation, PPQ and commercial launches.
• Participate in internal audits, supplier audits and regulatory inspections.

Skills

Quality Assurance

cGMP

Documentation

Quality Audits

GxP

Education

Bachelor's degree in science/engineering

Tools

eQMS

Veeva Quality

TrackWise

Job description

Cytokinetics is seeking a QA Specialist for Drug Product to oversee QA certification activities across CMOs, ensuring cGMP compliance for clinical and commercial manufacturing. You will review batch records, deviations and change controls, and support regulatory readiness.

You will collaborate with Regulatory, Technical Operations and Supply Chain to ensure product quality and smooth lifecycle management while maintaining a robust quality system in a fast-paced biopharma environment.