Director QA Operations – Global Pharma Quality Leader

Cytokinetics; Dublin; On-site; EUR 122,000 - 163,000; Full time

Benefits offered by this job

Stock options / RSUs

Health insurance

401k with employer match

Learning and wellness stipends

Paid time off

Job summary

Cytokinetics is seeking a Director, QA Operations in Dublin to lead QA oversight of Drug Substance and Drug Product manufacturing and testing across CMOs and CTLs. The role ensures compliance with global regulations, reviews GMP records, and guides quality strategy across the organization.

The Director will mentor QA staff, coordinate with Regulatory Affairs, Technical Operations, and Supply Chain, and support inspections and quality metrics to sustain product quality and patient safety.

Qualifications

• Experience leading and managing QA staff in a GMP environment.
• Proven ability to support regulatory inspections and audits.
• Knowledge of global GMP regulations and quality systems.

Responsibilities

• Lead QA oversight of DS/DP manufacturing, testing, release and lifecycle.
• Provide on-site QA support during manufacturing campaigns at CMOs/CTLs.
• Review batch records, analytical data, and GMP records for release.
• Oversee investigations, CAPAs, change controls and risk assessments.
• Support technology transfers, process validation and continued verification.
• Partner with internal and external stakeholders to drive improvement.

Skills

Team leadership

QA oversight

Regulatory inspections

Process improvement

Stakeholder engagement

Education

Bachelor's degree (BSc)

Tools

MS Office

Job description

Cytokinetics is seeking a Director, QA Operations in Dublin to lead QA oversight of Drug Substance and Drug Product manufacturing and testing across CMOs and CTLs. The role ensures compliance with global regulations, reviews GMP records, and guides quality strategy across the organization.

The Director will mentor QA staff, coordinate with Regulatory Affairs, Technical Operations, and Supply Chain, and support inspections and quality metrics to sustain product quality and patient safety.