Manager, Quality – Cell Therapy Site Onboarding (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.