Senior QA Specialist, Drug Substance (GxP)

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

Job summary

Cytokinetics Ireland is seeking a QA Specialist for Drug Substance to provide GMP quality assurance oversight across clinical and commercial manufacturing activities. You will review batch records, support QMS processes, and ensure compliance with cGMP and regulatory expectations.

The role involves collaboration with CMOs and other external partners, participation in audits, and support for technology transfers and lifecycle activities. A strong QA background in biopharma is essential.

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline.
• Minimum 5 years in biopharmaceutical/pharmaceutical QA, with at least 3 years in GMP QA.
• Experience supporting clinical or commercial pharmaceutical manufacturing.
• Experience reviewing GMP batch documentation and batch disposition activities.
• Experience with CMOs/CTLs and external manufacturing operations.

Responsibilities

• Provide GMP QA oversight for clinical and commercial manufacturing at CMOs.
• Review batch records and supporting documentation to ensure cGMP compliance.
• Review manufacturing and testing documentation to support batch disposition and release.
• Approve deviations, investigations, CAPAs, change controls and related QMS records.
• Support technology transfers, process validation, PPQ and commercial launch activities.
• Participate in internal and regulatory audits and inspection readiness activities.

Skills

Excellent communication

Cross-functional collaboration

Strong organizational skills

Attention to detail

Education

Bachelor's degree in scientific/engineering/technical discipline

Tools

Veeva Quality

TrackWise

Job description

Cytokinetics Ireland is seeking a QA Specialist for Drug Substance to provide GMP quality assurance oversight across clinical and commercial manufacturing activities. You will review batch records, support QMS processes, and ensure compliance with cGMP and regulatory expectations.

The role involves collaboration with CMOs and other external partners, participation in audits, and support for technology transfers and lifecycle activities. A strong QA background in biopharma is essential.