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Orca Bio

Posted 4 months ago

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Manager, Quality – Cell Therapy Site Onboarding (West Coast)

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AI Summary

Manages the quality onboarding process for commercial treatment sites (Authorized Treatment Centers) on the West Coast, coordinating with internal teams to ensure smooth, compliant implementation.

About this role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Position Summary: The Manager, Quality – Commercial Site Onboarding will oversee and manage the quality component of the onboarding process for our commercial sites (Authorized Treatment Centers) on the West Coast. This role will be responsible for ensuring a smooth, efficient, and high-quality onboarding experience, ensuring that all commercial sites are prepared for successful implementation and ongoing operations. The ideal candidate will have a strong background in project management, quality management or customer relationship management, ideally within biotech/bone marrow transplant/cell therapies, with a focus on delivering exceptional service and results.
Travel: up to 25-50% travel (to assigned Authorized Treatment Centers) will be required. Candidates must reside on the West Coast.

Responsibilities:

  • Lead and manage the end-to-end Quality onboarding process for commercial treatment sites (Authorized Treatment Centers), ensuring all steps are completed accurately, efficiently, and in alignment with company quality standards.
  • Coordinate with internal teams (account managers, case managers, MSLs, operations, and logistics) to ensure a seamless transition for new clients and commercial sites.
  • Develop and maintain a thorough understanding of client expectations, ensuring their needs are met throughout the onboarding process.
  • Conduct site assessments and audits to ensure compliance with quality standards and industry regulations.
  • Work closely with commercial teams to set clear onboarding timelines, objectives, and key milestones.
  • Monitor onboarding progress and proactively address any challenges or delays, ensuring clients and stakeholders are kept informed.
  • Provide guidance and training to new commercial partners on systems, tools, and best practices.
  • Collect and analyze feedback from stakeholders and clients to continuously improve the onboarding process and identify areas for improvement.
  • Develop and maintain documentation and resources related to onboarding processes, policies, and procedures.
  • Serve as the primary point of contact for clients during onboarding, addressing any questions, concerns, or issues promptly.
  • Collaborate with the quality assurance team to ensure all deliverables meet the company's quality standards.

    • Required Experience

  • Bachelor’s degree in Business Administration, Project Management, Healthcare or a related field (or equivalent work experience).
  • Minimum of 3-5 years of experience in onboarding, project management, and/or quality assurance, preferably within biotech/bone marrow transplant/cell therapy (e.g. CAR-T).
  • Proven experience managing complex projects with multiple stakeholders.
  • Strong knowledge of quality management principles and practices.
  • Excellent communication and interpersonal skills, with the ability to build strong relationships with internal teams and external customers.
  • Self starter who is highly organized with exceptional attention to detail and problem-solving skills.
  • Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.
  • Experience in commercial site operations, healthcare administration, FACT or similar industry experience is a plus.
  • Proficiency in project management software, CRM tools, and Microsoft Office Suite is a plus.

    • Skills

    BiotechCell TherapyCRMCustomer Relationship ManagementFactMicrosoft OfficeProject Management SoftwareQuality Management

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