Director of Quality Assurance, Alliance Management
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 judgment
- Excellent 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
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