Senior Quality Systems Specialist

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 Gaithersburg, 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.

How You’ll Make a Difference

In this role, you will provide quality administration for all elements of Arcellx’s QMS, ensuring we have a QMS quality unit that is compliant, effective, and agile to support a rapidly growing organization. Your work as part of our incredible Quality team will help us get our transformative therapy through clinical trials and to patients who need it most.

The “Fine Print” – What You’ll Do

• Execute day-to-day operations management of an electronic document/training management system (Veeva) and eQMS (e.g. document management, training and change control, audits and supplier management).
• Identify potential system enhancements, troubleshoot and investigate issues to ensure comprehensive and timely resolution.
• Create and administer job specific training curriculums for new GxP personnel.
• Manage Change Control process for new documents, revisions and supporting partner groups with documents management.
• Manage the maintenance of SOPs, training programs, supplier qualification/auditing, and documentation.
• Create and provide QMS key performance and key quality metrics to senior management as needed.
• Communicate and promote a culture of quality and operational excellence at Arcellx.

Skills and Experience We Look For

• Bachelor's degree, preferably in a scientific or technical discipline.
• 3-5+ years of experience in GxP and quality systems in biotechnology or pharmaceutical environment. Applicants with over 5 years of experience may be considered for a manager-level role.  
• 1-2 years of experience managing electronic Quality Management Systems with a history of successfully performing system enhancements and configuration updates.
• Demonstrated ability to thrive in the role, including excellent communication and collaboration skills, knowledge of applicable US and global compliance regulations and industry practices, etc.

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 $90,000 - $125,000 per year. Where a candidate falls within that range is determined by factors such as years of experience. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.

Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more. 

Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to www.arcellx.com.

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