Director Quality Operations - Supply Chain Oversight, 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 & 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 oversight 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 virtual operating model.

Essential Experience

• 10+ years of experience in pharmaceutical quality, supply chain, or a related field.
• Strong practical knowledge of EU Good Distribution Practice (GDP), including at least 5 years working in a Wholesale Distribution Authorisation (WDA) environment.
• Experience fulfilling the Responsible Person (RP) function for wholesale distribution, with HPRA accreditation or equivalent accreditation from another European agency.
• Experience establishing a GDP Quality system within a growing organisation.
• Experience managing or overseeing external logistics providers, distributors and/or wholesalers
• Experience with vendor agreements and contracts, audits, and applications for distribution licences.
• 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.
• Strong negotiation skills and the ability to make sound decisions in a developing supply chain environment.

Desirable Experience

• Experience within a virtual, emerging or rapidly scaling pharmaceutical/biotech organisation.
• Experience with OSD pharmaceutical products.
• 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.

Qualifications

• 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.

Personal Leadership Qualities

The successful candidate will be:

• Independent and objective – able to provide robust Quality oversight while working collaboratively with the business.
• Regulatory-minded – understands the expectations of regulators and translates them into practical systems.
• Commercially aware – understands business needs without compromising pharmaceutical Quality or compliance.
• Decisive – comfortable making and defending Quality decisions.
• Influential – able to achieve compliance through influence across internal and external organizations.
• Pragmatic – applies risk-based Quality management rather than unnecessary bureaucracy.
• Detail-oriented – maintains high standards of documentation and data integrity.
• Strategic – capable of developing a Quality organisation and systems that can scale with the business.
• Resilient and credible – able to lead during inspections, recalls, quality events and supply disruptions.
  
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Pay Range:

The salary range for this role in Dublin, Ireland is €130,400-€163,000 gross annually. Final compensation will depend on skills, experience, and internal equity considerations.

In line with Ireland equal pay regulations, we apply objective, gender-neutral criteria to determine compensation. We actively monitor pay equity through our annual Gender Equality Index and are committed to maintaining fair and transparent pay practices.

In compliance with Ireland pay transparency legislation, compensation for this role is based on objective criteria and is aligned with our company-wide salary register. We are committed to ensuring equal pay for work of equal value.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.  

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

• We will never request personal information such as banking details until after an official offer has been accepted and verified

• We will never request that you purchase equipment or other items when interviewing or hiring

• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [email protected]

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer