Sr Manager Quality Systems

Arcellx • Redwood City, CA

332d

About The Position

Arcellx is a clinical-stage biotech company focused on developing novel cell-based cancer therapies. The company is headquartered in Gaithersburg, MD and Redwood City, CA, and is committed to advancing humanity by engineering safer, more effective, and more accessible cell therapies. The Sr. Manager of Quality Management Systems (QMS) will report to the Sr. Director of Quality Systems and will be responsible for managing and administering the infrastructure and elements of the QMS department. This role is crucial for ensuring that the QMS quality unit is compliant, effective, and agile to support the rapidly growing organization.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees