Arcellx · 20 hours ago
Manager, Clinical Quality
Redwood City, CA
Full-time
Onsite
Mid, Senior Level
$125K/yr - $155K/yr
6+ years expArcellx is a public, clinical-stage biotechnology company focused on innovative immunotherapies for cancer treatment. As the Manager of Clinical Quality, you will oversee GCP quality for clinical studies, ensuring compliance with regulations and supporting clinical trial success.
BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical
Responsibilities
Act as a Clinical Quality lead by supporting study team compliance with national and international regulatory standards and guidance for cell therapy products
Develop audit plans and audit strategy for ongoing clinical trials
Performs initial and ongoing audit of clinical vendors
Coordinate, plan and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines
Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented
Participate in the development of clinical standard operating procedures, work instructions, forms, and templates
Develop and conduct training for staff (GCP, Inspection Readiness training, etc.)
Support preparation for and execution of regulatory inspections
Provide quality and regulatory compliance guidance to clinical colleagues
Qualification
Required
Bachelor's degree and 6+ years' experience working within GCP a pharmaceutical or biologics environment
Experience in Clinical Quality in a related industry (i.e. medical device or diagnostics) will be considered
Experience implementing and integrating clinical quality systems in CBER regulated biotechnology companies
Knowledge of applicable GCP regulations and industry guidance
Demonstrated ability to assess risk and prioritize effectively, with the ability to work with aggressive timeframes and adhere to project deadlines in a fast-paced environment
Strong communication and presentation skills with good relationship-building
Ability to travel up to 20% of time
Benefits
100% coverage for medical, dental and vision for team members and dependents
Unlimited vacation
A 3-day weekend every month
Fully-paid parental leave for up to 6 months
Tuition reimbursement
401k employer contribution
Company
Arcellx
Arcellx is a clinical-stage biotechnology company that provides patients with immune cell therapies.
51-200 employees
H1B Sponsorship
Arcellx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (4)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$622MKey Investors
Kite Pharma
2023-11-15Post Ipo Equity· $200M
2022-12-09Post Ipo Equity· $100M
2022-06-15Post Ipo Equity· $112M
Leadership Team
Michelle Gilson
Chief Financial Officer
Brad Gliner
Vice President, Clinical Research and Regulatory Affairs
Recent News
2025-12-11
Company data provided by crunchbase