Director, GDP Quality & Supply Chain Oversight (RP) - Virtual

Cytokinetics; Dublin; Presencial; EUR 130.000 - 163.000; Jornada completa

Descripción de la vacante

Cytokinetics, a specialty cardiovascular biopharmaceutical company in Dublin, is seeking an experienced Director of Quality Operations for Supply Chain Oversight and Responsible Person.

You will lead GDP quality framework and the Pharmaceutical Quality System, act as RP for WDA, oversee outsourced distribution, and drive regulatory readiness across EU and ROW. The role demands 10+ years in pharma quality, strong leadership, and collaboration with 3PLs and suppliers.

Formación

• 10+ years in pharmaceutical quality, supply chain or related field.
• Strong EU GDP knowledge with 5+ years in a WDA environment.
• Experience fulfilling the RP function, with accreditation recognized in Europe.
• Experience establishing a GDP Quality system within a growing organisation.
• Proven experience overseeing external logistics providers and suppliers.
• Track record of regulatory interactions and inspections.

Responsabilidades

• Lead GDP Quality framework and Pharmaceutical Quality System.
• Fulfil or oversee Responsible Person function for WDA and stay within scope.
• Provide independent Quality oversight across external supply chain.
• Lead audits, CAPAs, recalls, and regulatory inspections.
• Develop Quality Agreements with external partners and monitor performance.

Conocimientos

GDP Knowledge

Regulatory Affairs

Quality Leadership

Audits & Inspections

Vendor Management

Quality Systems

Strategic Thinking

Educación

Pharmacy Degree

Quality Assurance Training

RP Accreditation

Descripción del empleo

Cytokinetics, a specialty cardiovascular biopharmaceutical company in Dublin, is seeking an experienced Director of Quality Operations for Supply Chain Oversight and Responsible Person.

You will lead GDP quality framework and the Pharmaceutical Quality System, act as RP for WDA, oversee outsourced distribution, and drive regulatory readiness across EU and ROW. The role demands 10+ years in pharma quality, strong leadership, and collaboration with 3PLs and suppliers.