Associate Director, IT GxP Applications

Who We Are

Arcellx is a public, 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 destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.

Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.

What Matters to Us

Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.

Arcellx Core Values

• Character: Committed to always doing what’s right.
• Audacity: Willing to challenge convention and share candid feedback with others.
• Determination: Curious and self-motivated. Always looking to improve and learn.  
• Collaboration: "No job is too small" mentality. Humble and willing to help others.
• Originality: Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.

The “Fine Print” – What You’ll Do

• Manage the entire lifecycle of IT GxP systems, orchestrating seamless integrations between various GxP applications and systems and ensuring data integrity and compliance across platforms.
• Oversee stakeholder commitments and cross-functional deliverables for Tech Ops, Clinical Operations, Biometrics, Drug Safety, and other GxP-regulated departments.
• Develop and implement administration standard operating procedures (SOPs), assist the business teams with qualification and validation activities, and partner with Quality to oversee the validation lifecycle activities
• Oversee incident management and administrative activities, handle necessary escalations, and facilitate the resolution of incidents impacting core business systems.
• Develop and maintain GxP-related IT policies, procedures, and standards. Ensure that all GxP applications and related IT processes comply with relevant regulations.
• Manage relationships with vendors and service providers for GxP applications.
• Ensure the development and upkeep of business continuity and disaster recovery plans for vital GxP systems.

Skills and Experience We Look For

• Bachelor’s degree in computer science, engineering, or similar STEM concentration.
• 8+ years of direct IT experience in roles of increasing responsibility in project/program management, business analysis, or other delivery leadership roles within a life sciences IT organization.
• Strong understanding of IT infrastructure, system integration, data management, and Quality and Regulatory functions within regulated life sciences organizations.
• Demonstrated history of success executing the core functions of the role, including implementing standard GxP applications (e.g., LIMS, QMS, ERP, CTMS), SaaS systems, and implementing Incident, Problem Change, Version, Release, and Configuration management for GxP systems/applications.
• Experienced in gap analysis, remediation plans, corrective and preventive action (CAPA), and reviewing, modifying, and writing standard operating procedures (SOPs).
• Strong background in software/system development methodology (i.e., Agile, SDLC, ITIL) and project management/business analysis.
• Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements, standards, and guidelines.
• Adept at communicating complex solutions and value in business terms. Strong communication skills are critical, as well as the ability to adapt and learn in a fast-paced environment.
• Preferred but not required skills include experience with QMS, ServiceNow, and System Administration activities; proficiency in integration technologies and methodologies such as APIs, ETL, ESB, and middleware; experience with Veeva Vaults; and proficiency in process mapping and project management tools like Jira, Smartsheet, and Visio.

Rewards at Arcellx

Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.

The base salary range for this position is $190,000 - $210,000 per ye