- 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.
- 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.
- 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.
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Sr Manager Quality Systems - Redwood City, United States - Arcellx, Inc.
Description
Arcellx ) 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:
Requirements and Qualifications:
Competencies:
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.
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