Director Quality Operations/Qualified Person

Cytokinetics is seeking a Director of Quality Operations/Qualified Person to oversee compliance and quality for pharmaceutical products in Ireland. This role involves managing Quality Systems within the Quality Operations team and acting as a Qualified Person for EU product certification. The Director will also serve as the main contact for Quality aspects related to Cytokinetics' partnerships in ex-EU markets.

Responsibilities:

• Monitor and assess distribution processes to meet quality standards and regulatory requirements.
• Act as the Qualified Person (QP) as defined by EU regulations.
• Serve as the primary point of contact for regulatory authorities regarding GDP compliance.
• Identify potential risks in the distribution process and develop mitigation strategies.
• Lead investigations into quality issues, deviations, and complaints, implementing CAPA.
• Mentor and develop the GDP and quality assurance teams.
• Drive initiatives to enhance the efficiency and effectiveness of distribution operations.

Requirements:

• Bachelor’s degree in a relevant scientific discipline (e.g., Pharmacy, Life Sciences, Logistics); Master’s preferred.
• Qualified as Qualified Person per EU legislation.
• 8-10 years experience in Quality Assurance, Quality Control, and/or Quality Systems within the Pharmaceutical Industry.

Cytokinetics offers:

• Opportunity to play an integral part in advancing the mission to improve the lives of patients.
• A collaborative and compassionate work environment.