Sr Manager Quality Systems
Company: Arcellx Inc
Location: San Carlos
Posted on: April 2, 2026
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Job Description:
Arcellx ( http://www.arcellx.com/ ) is a clinical-stage biotech
company headquartered in Gaithersburg, MD and Redwood City, CA.
Arcellx is focused on the development of novel cell-based cancer
therapies. A team of biotechnology professionals with expertise in
biologics, discovery and tumor immunology incorporate proprietary
technologies into genetically engineered human immune cells
therapies. Arcellx’s mission is to advance humanity by engineering
cell therapies that are safer, more effective, and more broadly
accessible. Primary Objective: Arcellx is looking for a Sr. Manager
of Quality Management Systems (QMS) reporting to the Sr. Director
of Quality Systems. The Sr. Manager of QMS will manage and
administer the infrastructure and elements of the QMS department
ensuring a QMS quality unit that is compliant, effective, and agile
to support a rapidly growing organization. The candidate will
provide quality administration for all elements of Arcellx Quality
Management System (QMS), which includes: Change Control, Deviation
Management, Corrective and Preventive Action, Training, and
Document Control for all aspects including identification and
escalation of quality system and product issues. Main
Accountabilities: Execute day-to-day operations management of an
electronic document management system and Electronic Quality
Management System (e.g. Complaints, document management, training
and change control). Participate in the implementation and
enhancements of the various components of the Arcellx QMS function
ensuring adherence to established internal standards and in
compliance with applicable regulatory requirements. Manage the
maintenance of SOPs, training programs, deviations, CAPAs,
commercial/investigational product complaints, vendor
qualification/auditing, and the documentation of these activities.
Provide cross functional day to day support to any QMS related
requests or issues. Partner in troubleshooting and investigations
to ensure comprehensive and timely closure. Create and provide QMS
Key Performance and Key Quality Metrics to senior management and
executive management as needed. Maintain records management system
including master inventory, secure storage, retrieval, retention
and destruction. Provide QMS support and subject matter expertise
during Health Authority inspections authority. Participate in
inspection readiness efforts. Represent QA on project teams for
assigned QMS topics or initiatives. Support continuous improvement
planning. Communicate and promote a culture of quality and
operational excellence at Arcellx. Requirements and Qualifications:
A Bachelor's degree in a scientific or technical discipline is
required. A minimum of 7-9 years of experience in GxP and Quality
Systems in biotechnology or pharmaceutical environment is required.
Experience in implementing and managing electronic Quality
Management Systems. Experience in participating in high performing
teams. Experience in Inspection Readiness. Knowledge of applicable
US and Global compliance regulations and industry practices.
Ability to critically evaluate and troubleshoot complex problems
and attention to detail. Strong teamwork, collaboration and
management skills. Ability to manage multiple priorities and
aggressive timelines. Competencies: • Commitment to ethical
scientific investigations and rigorous experimental methods. •
Ability and desire to multitask and function in a fast-paced
entrepreneurial environment. • Sense of urgency in performance of
duties. • Interpersonal skills that promote a collaborative and
productive lab environment. • Effective and efficient written and
oral communication skills. Submit cover letter and resume Without
exception, applicants must submit both a cover letter and resume to
be considered for these positions and must have experience in one
of the fields listed above.
Keywords: Arcellx Inc, San Leandro , Sr Manager Quality Systems, Science, Research & Development , San Carlos, California
