Manager, GMP Quality Operations

 

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. We believe 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.

Primary Objective

Arcellx is looking for a Manager of GMP Quality Operations to be responsible for supporting the quality assurance program. Reporting to the Associate Director of GMP Quality Operations, the Manager/Senior Manager of GMP Quality Operations will provide day to day quality support to the various Arcellx GMP-relevant functions and will be responsible for the administration of quality standards, internal practices and continuous improvement as it relates to internal technical operations and collaborations with manufacturing vendors.

 

Main Accountabilities:

• Support Management Quality Reviews and Product Reviews.
• Lead review and release of clinical trial material for on-going and future studies.
• Create, review and approve GMP related documentation including but not limited to SOPs, batch records, specifications, master manufacturing records, analytical methods, labeling, protocols, etc.
• Coordinate investigations, including development and implementation of corrective actions.
• Manage change control review and implementation with internal and external stakeholders.
• Support internal and external audits.
• Collaborate with cross functional team member to resolve quality issues.
• Assist with validation activities related to facilities, equipment, processes, and computerized systems at contract sites.
• Support the collection of key quality metrics.
• 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. 
• Experience in a GxP biotechnology or pharmaceutical environment is required. Biologics/Cell Therapy experience preferred.
• Knowledge and experience in quality assurance and in a highly regulated manufacturing environment.
• Experience working with Contract Manufacturing Organizations.
• Experience with regulatory inspections preferred.
• Extensive knowledge of US cGMP and GDP compliance regulations and industry practices, as well as EU GMP requirements.
• Ability to critically evaluate and troubleshoot complex problems and attention to detail.
• Ability to manage multiple priorities and aggressive timelines

 

 Competencies:

• Commitment to integrity and always doing what’s right
• Self-motivated and able to work autonomously
• Produces top-quality work with little oversight
• Demonstrated ability to juggle multiple priorities in a fast-paced, entrepreneurial environment
• Direct and candid, willing to challenge the status quo
• Able to build strong relationships and collaborate effectively with colleagues