VP of Quality (Quality Assurance and Quality Control)

Summary: Arcellx is seeking a Vice President of Quality to join our fast paced, high-growth biotechnology company and be an important part of our mission to develop novel, adaptive and controllable cell therapies for the treatment of patients with cancer and autoimmune diseases. The Vice President of Quality will be responsible for the strategic development and execution of  quality assurance and controls including all quality decisions. This position will be responsible for the execution and administration of GXP Quality Systems to support cGMP, GLP, GCP and GvP compliance in accordance with ICH, US, EU and other relevant country regulations. The VP of Quality is expected to lead a team and collaborate across the organization on all quality matters and develop strong relationships with external consultants/contractors as necessary. In particular, this role will partner closely with the Regulatory Affairs and Supply Chain teams to ensure that quality is designed (QBD) throughout the discovery and clinical phases to ensure registration success and long term scalability.  This position requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP) and relevant regulation. The successful candidate will drive, promote and embed a culture of ethics, integrity and continuous improvement that will focus on delivering efficiencies.

ABOUT ARCELLX:  Arcellx is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is located in Gaithersburg, Maryland and has assembled a veteran team of biotechnology industry professionals who are developing our ARC-sparX platform that incorporates 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.

The QA Responsibilities will include, but are not limited to:

• Serves as the strategic leader and operational manager to direct, oversee and manage all quality assurance activities.
• Drives the design, analysis and oversight of global, phase-appropriate Quality Management System (QMS) Structure to ensure compliance to applicable regulations, including U.S. and EU.
• Maintains ethical business practices and adherence to Arcellx's quality policies, and directs, oversees and manages initiatives established for adherence to these quality policies at all levels of the organization.
• Directs, oversees and manages the quality oversight of GxP activities (including SOP/policy development and maintenance, internal and external audit functions, clinical and planned commercial batch release program) to ensure patient safety and data integrity.
• Partners with the R&D organization to ensure robust analytical and process strategy including the development and implementation of robust critical quality attributes (CQA) required for registration and future product release.
• Defines, implements and executes strategy with multiple US CDMO partners and Arcellx sites to ensure product is consistently developed, manufactured, tested, labeled, released, and shipped to meet domestic and international regulations including FDA and EU GxP requirements.
• Develops quality operational strategies by establishing critical quality and operational metrics and measurements; conducting trend analysis; system design and implementation.
• Provides leadership, direction, and mentorship across all levels of the organization to assure quality assurance and validation strategies are known and implemented.
• Hires, develops, and retains QA personnel (including contract staff) to create a high-performing team that exemplifies best quality practices.

Quality Control Responsibilities will include, but are not limited to:

• Maintains and operates the company's Quality Control testing laboratories, equipment, standards, and procedures in compliance with GMP standards.
• Prepares, reviews, and approves external and internal protocols and other documentation as required to support external testing lab services.
• Provides technical expertise and assists in the development and maintenance of raw material specifications.
• Performs and completes Change Control, Investigations, and Corrective/Preventive Actions associated with QC and/or process deviations.
• Effectively cooperates with departments across the company to analyze and resolve technical issues in accordance with appropriate quality standards
• Performs special assignments in assay tech transfer, validation, or other technical projects
• Develops and maintains collaborations with counterparts at Arcellx subsidiaries and partners
• Hires, develops, and retains QC personnel (including contract staff) to create a high-performing team that exemplifies best quality practices.

Minimum requirements:

• Degree in biological science. MS/Ph.D. preferred.
• 15+ years' experience in GMP pharmaceutical, biologics and/or vaccine manufacturing. Cell therapy experience strongly preferred.
• Experience in senior roles in both QA and QC (minimum 5 years in each area)
• Minimum 5 years supervisory experience.
• Demonstrated success designing and implementing QA and QC policies, procedures, and systems. Clinical stage experience required, commercial stage experience a plus.
• Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications.
• Knowledgeable of FDA regulations and ICH Guidelines regarding the manufacture of biological products and experience working with global health authorities on novel therapeutic platforms
• Knowledge of quality compliance standards and risk management.
• Experience validating and commissioning facilities preferred.
• Excellent multi-tasking, analytical, organizational and leadership skills.
• Strong written and verbal communication skills.
• Ability to troubleshoot, identify root cause and systematically resolve problems.

 COMPETENCIES:

• Must have strong organizational skills and an ability to handle track and execute multiple priorities
• Highly motivated, with willingness to acquire new skills and ability to learn quickly
• Strong engineering/scientific understanding, and ability to apply knowledge to process development
• Detail oriented, good documentation practices, technical writing and verbal communication skills
• Possess strong problem solving and analytical skills and be an independent and creative thinker
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
• Interpersonal and leadership skills to work with teams in different functions and organizations

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.