Arcellx (http://www.arcellx.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company has a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells. Arcellx’s vision is to bring ARC-sparX platform cell therapies to millions of patients who can self-administer prescribed sparX proteins under the care of academic and community practices.
- Arcellx is looking for a Director Quality Management Systems (QMS) reporting to the VP of Quality.
- The Director of QMS will establish and manage the infrastructure and elements of the QMS department ensuring the QMS quality unit that is compliant, effective, and agile to support a rapidly growing organization.
- The candidate will provide quality management oversight for all elements of Arcellx Quality Management System (QMS), which includes: Change Control, Deviation Management, Corrective and Preventive Action, Training, Document Control, Production and Process Controls, Facilities and Equipment Controls, and Material Controls for all aspects including identification and escalation of quality system and product issues.
- Define and implement quality standards and systems for development and commercial operations.
- Lead 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.
- Prepare QMS Key Performance and Key Quality Metrics to senior management and executive management as needed.
- Develop and implement the GxP e-Quality Systems, ensuring compliance to regulatory requirements, policies, standards, and procedures, as they relate to computerized systems, data integrity, and validation.
- Ensure the health of Arcellx QMS and lead the team in continuous improvement and planning for scalability.
- Act as QMS Point of Contact and subject matter expert during Health Authority inspections authority.
- Provide cross functional day to day support to any QMS related requests or issues. Partner in troubleshooting and investigations to ensure closure.
- Responsible for operational support for key quality systems (e.g. Complaints, document management, training and change control)
- Partner with the VP of Quality in creation of department goals and metrics.
- Represent QA on project teams and act as the main Quality point of contact for all related QMS topics or initiatives.
- 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. An advanced degree is preferred.
- A minimum of 12 years of experience in a GxP and Quality Systems in biotechnology or pharmaceutical environment is required.
- Experience in establishing infrastructure and leading QMS functions including QMS IT systems.
- Experience in building high performing teams.
- Experience in developing and implementing Inspection Readiness and PAI Plans.
- Extensive knowledge of applicable US and Global compliance regulations and industry practices.
- Ability to critically evaluate and troubleshoot complex problems and attention to detail.
- Strong leadership, 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.
Submit cover letter and resume to: firstname.lastname@example.org
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.