Senior Manager, Quality Systems

Arcellx, Inc. (http://www.arcellx.com/) is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and our mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Our offices are located in Gaithersburg, Maryland, and Redwood City, California.

Arcellx's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (r/r MM) in an ongoing study. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration.

Arcellx is also advancing its dosable and controllable CAR-T therapy, ARC-SparX, through two programs: ACLX-001 for r/r MM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

We are looking for a Senior Manager of Quality Management Systems (QMS) reporting to the Senior Director of Quality Systems. This role 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 successful candidate will provide quality administration for all elements of Arcellx’s QMS, which includes: change control, deviation management, corrective and preventive action, training, document control, and identification and escalation of quality system and product issues.

At Arcellx, we value passion, curiosity, determination, and diversity, and look for candidates who demonstrate a genuine interest in our mission and alignment with our values.     

Key Responsibilities: 

• Execute day-to-day operations management of an electronic document management system and eQMS (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 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.
• 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.

Qualifications: 

• Bachelor's degree in a scientific or technical discipline.
• Minimum of 7-9 years of experience in GxP and quality systems in a biotechnology or pharmaceutical environment.
• 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:

• Has character and integrity. Committed to always doing what’s right.
• Self-motivated and able to work autonomously. Can produce top-quality work with little oversight.
• "No job is too small" mentality. Humble and willing to help others.
• Able to build strong relationships and collaborate effectively with colleagues.
• Gives direct, candid, and respectful feedback. Can receive feedback with curiosity and without getting defensive.
• Always looking to improve and challenge the status quo. Gritty and determined.