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

2 weeks, 3 days ago
United States
Full-time
Mid Level
Program Manager
Quality Assurance and Testing
CRM
Apply Now
Orca Bio

Orca Bio

Orca Bio is revolutionizing allogeneic cell therapy with next-gen therapies for better outcomes and fewer risks, transforming lives through precision and innovation.

Pharmaceuticals
51-250
Founded 2016
$192M raised
View All Jobs 5

Description

  • Lead the end-to-end quality onboarding process for commercial treatment sites, ensuring accuracy, efficiency, and alignment with company quality standards.
  • Coordinate with account managers, case managers, MSLs, operations, and logistics teams to support a seamless transition for new clients and sites.
  • Develop and maintain a clear understanding of client expectations and ensure those needs are met throughout onboarding.
  • Conduct site assessments and audits to verify compliance with quality standards and industry regulations.
  • Set onboarding timelines, objectives, and key milestones in collaboration with commercial teams.
  • Monitor onboarding progress and proactively resolve delays or challenges while keeping clients and stakeholders informed.
  • Provide guidance and training to new commercial partners on systems, tools, and best practices.
  • Collect and analyze stakeholder and client feedback to improve onboarding processes.
  • Develop and maintain onboarding documentation, resources, policies, and procedures.
  • Serve as the primary point of contact for clients during onboarding and coordinate with the quality assurance team on deliverables.

Requirements

  • Bachelor’s degree in Business Administration, Project Management, Healthcare, or a related field, or equivalent work experience.
  • 3-5 years of experience in onboarding, project management, and/or quality assurance.
  • Experience in biotech, bone marrow transplant, or cell therapy environments, preferably 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 internal and external relationships.
  • Highly organized self-starter 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, or FACT is a plus.
  • Proficiency with project management software, CRM tools, and Microsoft Office Suite is a plus.
  • Candidates must reside on the West Coast.
  • Willingness to travel 25-50% to assigned Authorized Treatment Centers.

Benefits

  • Pre-IPO equity for full-time employees.
  • Annual bonus eligibility.
  • Competitive medical, dental, and vision benefits.
  • PTO.
  • 401(k) plan.
  • Life insurance and accidental death and disability coverage.
  • Parental leave benefits.
  • Subsidized daily lunches and snacks at on-site locations.

Interested in this position?

Apply directly on the company website

Apply Now

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