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

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

* 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.* 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.* 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 external logistics providers, distributors and/or wholesalers.* Strong experience with Quality Management Systems and pharmaceutical quality processes.* Experience with supplier qualification, audits and Quality Agreements.* Experience managing deviations, CAPAs, change controls, complaints and recalls.* Experience interacting with regulatory authorities and supporting regulatory inspections.* Demonstrated ability to operate at senior management level.* Ability to exercise independent Quality judgement and challenge operational decisions where required.* Experience within a virtual, emerging or rapidly scaling pharmaceutical/biotech organisation.* Experience with OSD pharmaceutical products.* Experience managing a WDA within Ireland or the EU.* Experience with outsourced manufacturing and distribution models.* Experience with temperature-controlled pharmaceutical distribution.* Experience with product serialization and supply-chain traceability.* Experience with multiple European markets.* Experience establishing a GDP Quality system within a growing organisation.* Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry or a related discipline.* Relevant postgraduate qualification in Quality Assurance, Regulatory Affairs or a related field is desirable.* Appropriate training and experience to fulfil the Responsible Person requirements applicable to the company's WDA.* Demonstrable continuing professional development in pharmaceutical Quality and GDP.