Director, Quality Operations, Supply Chain Oversight & EU Responsible Person at Cytokinetics

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. We are seeking an experienced Director of Quality Operations for Supply Chain Oversight & Responsible Person to lead the company's pharmaceutical Good Distribution Practice (GDP) Quality function and provide senior oversight of the quality and compliance aspects of our outsourced distribution operations. This is a leadership role within a virtual pharmaceutical organisation, with responsibility for ensuring that the company's distribution activities are conducted in compliance with applicable pharmaceutical legislation, EU and Rest of World, Good Distribution Practice (GDP) requirements and the company's Pharmaceutical Quality System. The successful candidate will have responsibility for the Responsible Person function associated with the company's Wholesale Distribution Authorisation (WDA) and will provide independent Quality oversight of the external distribution network , including third-party logistics providers, wholesalers, distributors and other service providers. The role combines strategic Quality leadership with hands-on oversight of GDP activities and will be central to maintaining a robust, inspection-ready quality system within an asset-light and highly outsourced operating model. Key Duties and Responsibilities: Quality Leadership & Responsible Person Lead and continuously improve the company's GDP Quality framework and Pharmaceutical Quality System. Fulfil or oversee the Responsible Person function for the WDA and ensure wholesale distribution remains within the authorised scope. Provide independent Quality oversight across the external supply chain and maintain clear governance between Quality and Supply Chain. Act as a senior Quality contact for regulatory authorities on GDP and WDA matters. Ensure appropriate controls for sourcing, receipt, storage, transportation, traceability, returns, recalls and product quality issues. GDP Compliance & Quality Systems Ensure compliance with applicable EU and Irish GDP requirements and translate regulatory expectations into effective policies, SOPs and controls. Oversee key GDP processes including deviations, CAPAs, complaints, recalls, temperature excursions, damaged/defective products and suspected falsified medicines. Ensure appropriate GDP training and maintain a high level of ongoing inspection readiness. External Partner Oversight Lead Quality o versight of 3PLs, distributors, wholesalers and other GDP-critical service providers. Establish supplier qualification, audit and monitoring programmes using a risk-based approach. Develop and maintain Quality/Technical Agreements with external partners. Monitor partner performance through audits, quality metrics and management reviews, ensuring significant issues are escalated and resolved. Audits & Regulatory Inspections Establish and manage the GDP audit programme, including audits of critical suppliers and distribution partners. Oversee audit follow-up, CAPAs and effectiveness checks. Lead preparation for and represent the company during regulatory inspections relating to Quality, GDP and WDA activities. Leadership in a Virtual Organisation Provide Quality leadership across an organisation where significant operational activities are outsourced. Manage Responsible Person personnel in the UK and Switzerland. Build effective relationships with internal and external stakeholders while maintaining Quality independence and appropriate regulatory challenge. Establish scalable, risk-based Quality governance across the external network. Qualifications, Knowledge and Skills Required: We are seeking a senior pharmaceutical Quality professional with substantial experience in GDP, pharmaceutical distribution and Quality systems, ideally within an outsourced or vi