Senior Drug Substance QA Leader

Cytokinetics (Ireland) Limited; Ireland; Hybrid; EUR 78,000 - 98,000; Full time

Job summary

Cytokinetics (Ireland) Limited is seeking a QA Specialist for Drug Substance to provide GMP QA oversight across clinical and commercial manufacturing activities. The role involves review of batch documentation, deviation handling, CAPAs and change controls, with support to the QP function.

The successful candidate will collaborate with Regulatory Affairs, Technical Operations and Supply Chain, participate in audits and inspections, and drive continuous improvement within Cytokinetics' Quality

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline.
• Minimum 5 years of experience in biopharmaceutical or pharmaceutical QA with at least 3 years in GMP QA.
• Experience supporting clinical and/or commercial manufacturing.
• Experience reviewing GMP batch documentation and supporting batch disposition activities.
• Experience auditing CMOs/contract labs and supporting regulatory inspections.
• Excellent written and verbal communication across functions.

Responsibilities

• Provide GMP QA oversight for clinical and commercial manufacturing and distribution activities at CMOs/CTLs.
• Review batch records and supporting documentation to ensure compliance with cGMP and regulatory filings.
• Review and approve deviations, investigations, CAPAs, change controls and QMS records.
• Assess quality events for product impact and support risk-based quality decisions.
• Support technology transfers, process validation, PPQ and commercial launch activities.
• Participate in internal and regulatory audits and inspection readiness.

Skills

GMP Quality Assurance

QA Documentation Review

Regulatory Compliance

Internal/External Audits

Cross-functional Collaboration

cGMP Experience

Documentation Management

eQMS Systems Familiarity

Education

Bachelor's degree in scientific, engineering or technical discipline

Tools

Veeva Quality

TrackWise

eQMS software

Job description

Cytokinetics (Ireland) Limited is seeking a QA Specialist for Drug Substance to provide GMP QA oversight across clinical and commercial manufacturing activities. The role involves review of batch documentation, deviation handling, CAPAs and change controls, with support to the QP function.

The successful candidate will collaborate with Regulatory Affairs, Technical Operations and Supply Chain, participate in audits and inspections, and drive continuous improvement within Cytokinetics' Quality