Manager, Clinical Quality
About The Position
Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Our team members are made up of talented innovators and dreamers working from our offices in Gaithersburg, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work. As our Manager, Clinical Quality, your mission is to support all GCP quality oversight as it relates to Arcellx’s phase I, II and III clinical studies. Partnering with clinical and medical affairs, you’ll ensure our quality system provides sufficient oversight and is compliant with applicable regulations for our GCP programs and activities. In this role, your work will directly impact our ability to run successful clinical trials and get our potentially life-saving therapy to patients.
Requirements
- 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. More experienced candidates may be considered at the senior level.
- 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.
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.
Benefits
- Our market-leading benefits package includes: 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 and more.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
101-250 employees
