About the role
<div class="content-intro"><p>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.</p></div><p>We are seeking an experienced <strong>Director of Quality Assurance, Alliance Management</strong> 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.</p> <p>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.</p> <p>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.</p> <p><strong><br>Key Responsibilities</strong></p> <ul> <li>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</li> <li>Lead and manage all Quality Assurance activities related to the onboarding of new partners</li> <li>Develop scalable frameworks, models, and processes for partner onboarding and QA integration</li> <li>Act as the lead for partner-related Quality Assurance audits</li> <li>Develop standards for Quality Agreements supporting in-licensing partnerships in collaboration with Quality Compliance</li> <li>Review and approve (as applicable) change controls, deviations, investigations, procedures, and CAPAs related to partner supply</li> <li>Participate in Quality Management Review meetings, providing input on partnership-related quality topics</li> <li>Collaborate with Quality Systems and Compliance to ensure the QMS meets market-specific regulatory requirements associated with partnerships</li> <li>Ensure timely and effective resolution of quality issues related to product supply for partners</li> <li>Conduct risk assessments and implement appropriate controls when onboarding new partners</l