Director of Quality Assurance, Alliance Management
Dublin, Dublin, Ireland
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
We are seeking an experienced Director of Quality Assurance, Alliance Management to join our growing global organization. As Cytokinetics expands through strategic in-licensing partnerships with regional market leaders, this role will be critical in ensuring that all quality and compliance aspects of these partnerships are effectively established and maintained.
This position will lead and coordinate Quality Assurance activities across partner relationships, ensuring alignment with global regulatory requirements and internal standards. The successful candidate will act as a key liaison between Cytokinetics and its partners, supporting both the onboarding of new alliances and the ongoing management of established collaborations. The role reports to the Head of Quality Assurance Operations and works closely with Alliance Management, Technical Operations, Regulatory CMC, and other cross‑functional teams.
Key Responsibilities
Serve as a core member of the QA Operations team and Point of Contact (POC), coordinating quality requirements arising from partnership activities, in partnership with alliance management teams
Lead and manage all Quality Assurance activities related to the onboarding of new partners
Develop scalable frameworks, models, and processes for partner onboarding and QA integration
Act as the lead for partner-related Quality Assurance audits
Develop standards for Quality Agreements supporting in‑licensing partnerships in collaboration with Quality Compliance
Review and approve (as applicable) change controls, deviations, investigations, procedures, and CAPAs related to partner supply
Participate in Quality Management Review meetings, providing input on partnership‑related quality topics
Collaborate with Quality Systems and Compliance to ensure the QMS meets market‑specific regulatory requirements associated with partnerships
Ensure timely and effective resolution of quality issues related to product supply for partners
Conduct risk assessments and implement appropriate controls when onboarding new partners
Partner with Technical Operations, Regulatory CMC, and other functions to ensure GMP compliance across new markets and partnerships
Support review of Product Quality Reviews (PQRs) as part of partner oversight
Represent the QA function in cross‑functional and external meetings, making decisions within scope of responsibility
Promote a culture of quality, compliance, and continuous improvement across the organization
Identify and lead initiatives to enhance quality systems, processes, and practices
Qualifications & Experience
Bachelor’s degree (BSc) or higher in a relevant scientific discipline
Minimum of 10 years’ experience in pharmaceutical or biopharmaceutical manufacturing and quality functions
Strong knowledge of global cGMP regulations and emerging regulatory trends
Experience in a biopharma or pharmaceutical start‑up environment
Preference for experience hosting regulatory inspections and/or partner/client audits
Demonstrated ability to influence and collaborate effectively across all organizational levels
Experience working with external partners, alliances, or contract organizations
Strong ability to work independently, demonstrating initiative and sound judgmentExcellent organizational skills with the ability to manage multiple priorities effectively
Strong written and verbal communication skills
Proficiency in Microsoft Office applications
Fluency in English; additional language(s) are an advantage
Willingness to travel up to 15% annually
Cytokinetics is an Equal Opportunity Employer
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