Global Quality Assurance Manager
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The role of a Global Quality Assurance Manager is to ensure consistency in operational oversight of Apheresis Network Onboarding and Maintenance. This involves troubleshooting within this scope to support clinical and commercial operations.
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This manager will act as regional Quality Single Point of Contact, providing real-time support for quality events. They will make decisions regarding apheresis collection, shipping patient materials, and resolving chain of identity discrepancies.
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Key responsibilities include:
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1. Supporting the development and review of Patient Operations processes and procedures related to Scheduling, Apheresis Onboarding, Distribution, and CDP On-Site Storage.
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2. Collaborating with stakeholders to maintain robust handling and chain of identity standards throughout the product lifecycle.
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3. Providing quality review and approval of training materials, procedures, apheresis accounts (JAMS), risk assessments, and commercial readiness documentation for Apheresis Network onboarding and maintenance.
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4. Assisting with deviation management, change management, complaints, CAPA, and compliance guidance.
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5. Maintaining Key Performance Indicators to ensure continuous improvement.
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6. Interface with regional clinical specialists and Commercial Launch Excellence Managers.
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7. Assisting with regulatory inspections and developing remediation efforts and responses, identifying opportunities for improvement and driving CAPA and change control.
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8. Modeling effective communication behaviors with technical departments.
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9. Serving on project teams, providing quality assurance guidance and supporting project activities related to quality systems.
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10. Representing quality and directing Patient Operations and technical teams.
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Requirements
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11. The ideal candidate will have strong interpersonal skills, including communication, coaching, inspiring team goals, delivering training, establishing collaboration, and managing interfaces.
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12. They must be able to work independently or with teams in a complex, changing environment, demonstrating flexibility and adaptability to change.
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13. Enterprise mindset and external focus are essential, along with negotiation, risk management, relationship management, and conflict resolution skills.
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14. The candidate should have in-depth knowledge of global health authority regulations, quality systems principles, and pharmaceutical industry applications.
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15. Bachelor's degree in biochemistry, biology, microbiology, chemistry, engineering, or related fields is required, with at least 2 years of experience in Quality Assurance or Quality in regulated environments.
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16. Experience supporting cellular therapy operations is beneficial, as is advisory skills regarding quality requirements, leadership, influence, and negotiation skills.
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17. Innovative, proactive, resourceful, committed to quality and continuous improvement – these qualities are highly valued in the ideal candidate.
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18. Excellent communication skills in Japanese and English are necessary for success in this role.
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Benefits
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The successful candidate can expect a challenging yet rewarding role with opportunities for growth and development. If you possess the necessary skills and qualifications, we encourage you to apply.
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19. We offer a dynamic work environment with opportunities for professional growth and development.
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20. A competitive salary and benefits package.
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21. Opportunities for advancement and professional development.
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Contact Information
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Please note that only applicants eligible to work in Switzerland will be considered. We look forward to hearing from you.