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

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

• •Establish, maintain and continuously improve the GDP aspects of the company Quality System.
• •Ensure that quality systems are appropriately designed for a virtual pharmaceutical organisation with outsourced distribution activities.
• •Provide independent Quality oversight of supply-chain and distribution operations.
• •Establish a strong culture of quality, compliance, risk management and continuous improvement.
• •Provide input into Quality Assurance team strategy planning and , product launches, market expansion and operational decision-making.

Responsible Person / WDA

• •Fulfil, or oversee the fulfilment of, the Responsible Person function associated with the company's Wholesale Distribution Authorisation in accordance with applicable regulatory requirements.
• •Ensure that the WDA is maintained appropriately and that wholesale distribution activities remain within the authorised scope.
• •Provide appropriate oversight of all activities conducted under the WDA.
• •Ensure that responsibilities, authorities and interfaces between the company and its external distribution partners are clearly defined.
• •Ensure that products distributed under the WDA are appropriately sourced, received, stored, supplied and transported in accordance with applicable requirements.
• •Ensure that appropriate controls are established for the qualification and ongoing oversight of suppliers and customers.
• •Maintain appropriate oversight of product traceability, distribution records and documentation.
• •Ensure that the Responsible Person function has sufficient authority, resources and independence to discharge its responsibilities effectively.
• •Act as the principal Quality contact for regulatory authorities in relation to GDP and WDA matters, as appropriate.

GDP Compliance

• •Own the company's GDP compliance framework and ensure effective implementation across the external distribution network.
• •Maintain oversight of applicable EU and Irish GDP requirements and translate regulatory expectations into effective company procedures and controls.
• •Ensure that distribution partners operate in accordance with agreed GDP requirements.
• •Establish and maintain appropriate GDP policies, SOPs and quality standards.
• •Ensure appropriate controls are in place for:
• •Receipt and release of pharmaceutical products
• •Storage and transportation
• •Temperature-controlled distribution, where applicable
• •Product traceability
• •Returns
• •Recalls
• •Suspected falsified medicines
• •Damaged or defective products
• •Temperature excursions
• •Deviations and non-conformances
• •Product destruction
• •Complaints and quality defects

Ensure GDP training requirements are defined and appropriately implemented.

External Partner Quality Oversight

• •Lead Quality oversight of third-party logistics providers, distributors, wholesalers and other critical service providers.
• •Establish appropriate qualification and approval processes for GDP-critical suppliers and service providers.
• •Develop and maintain appropriate Quality Agreements / Technical Agreements with external partners responsible for Supply Chain activites.
• •Establish audit and monitoring programmes based on risk.
• •Monitor external partner performance through quality metrics, audits, management reviews and quality events.
• •Ensure that significant quality or compliance issues are appropriately escalated and resolved.
• •Maintain clear governance between operational ownership by Supply Chain and independent Quality oversight.

Audits & Regulatory Inspections

• •Establish and manage the company's GDP audit programme.
• •Conduct or oversee audits of critical suppliers, 3PLs and distribution partners.
• •Ensure appropriate follow-up, CAPA management and effectiveness checks following audits.
• •Lead the company's preparation for regulatory inspections relating to Quality, GDP and WDA activities.
• •Act as a senior company representative during regulatory inspections and provide appropriate responses to regulatory observations.
• •Ensure inspection readiness is maintained on an ongoing basis rather than being treated as a periodic activity.

Relationship with Supply Chain & Distribution

In this role, you will work closely with the internal stakeholders within the Supply Chain & Distribution function, while maintaining appropriate Quality independence.

The distinction between the functions will be clear:

Supply Chain & Distribution will be responsible for operational and commercial performance, including logistics, inventory, service levels, cost and external partner management.

Quality & Responsible Person will be responsible for independent Quality oversight, GDP compliance, WDA requirements, quality systems, supplier qualification, audits, deviations, CAPAs, recalls and other regulatory Quality matters.

Leadership of a Virtual Quality Organisation

As a virtual pharmaceutical company, the successful candidate will be required to provide effective Quality leadership across an organisation where significant operational activities are performed by external partners.

This will require the ability to:

• •Establish clear Quality ownership across organisational boundaries.
• •Manage Responsible Person personnel in UK and Switzerland.
• •Govern outsourced activities without unnecessarily duplicating the activities of service providers.
• •Maintain appropriate independence between Quality oversight and commercial/operational decision-making.
• •Build strong relationships with external partners while maintaining appropriate regulatory challenge.
• •Establish effective Quality governance using risk-based oversight.
• •Maintain a high level of inspection readiness.
• •Ensure that the company's Quality standards are consistently understood and implemented throughout 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 virtual operating model.

Essential Experience

• •Significant experience in pharmaceutical Quality Assurance.
• •Strong knowledge and practical experience of EU Good Distribution Practice (GDP).
• •Experience with pharmaceutical wholesale distribution and/or a Wholesale Distribution Authorisation (WDA) environment.
• •Experience fulfilling or supporting a Responsible Person function for wholesale distribution.
• •Experience managing or overseeing e