EU GDP & WDA Quality & Supply Chain Director

Cytokinetics; Ireland; On-site; EUR 90,000 - 130,000; Full time

Job summary

Cytokinetics Ireland is seeking an experienced Responsible Person to oversee GDP/WDA compliance across our wholesale distribution operations and to act as the primary regulatory liaison.

You will own the GDP framework, ensure partner oversight, product traceability, QA controls, deviations and recalls handling, and preparation for regulatory inspections, while maintaining independence and senior management visibility.

Qualifications

• Extensive experience in pharmaceutical QA and GDP.
• Proven track record in wholesale distribution and WDA environments.
• Experience fulfilling or supporting a Responsible Person role.
• Experience with regulatory authorities and inspections.
• Senior leadership experience in pharma quality (comms, governance).

Responsibilities

• Oversee Responsible Person function and GDP programme.
• Ensure WDA compliance and partner controls.
• Maintain product traceability and distribution records.
• Lead supplier qualification, audits, and quality agreements.
• Act as regulatory liaison and manage inspections.

Skills

GDP knowledge

Quality Assurance

Regulatory affairs

Stakeholder management

Audits & QA agreements

Education

Bachelor in Pharmacy or Life Sciences

Postgraduate QA/Reg Affairs desirable

Job description

Cytokinetics Ireland is seeking an experienced Responsible Person to oversee GDP/WDA compliance across our wholesale distribution operations and to act as the primary regulatory liaison.

You will own the GDP framework, ensure partner oversight, product traceability, QA controls, deviations and recalls handling, and preparation for regulatory inspections, while maintaining independence and senior management visibility.