Manager, GMP Quality Operations

Arcellx • Redwood City, CA

122d • $125,000 - $155,000

About The Position

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.

Requirements

• Bachelor’s degree in a scientific or engineering discipline (or equivalent experience).
• 6+ years of experience in GMP Quality Assurance or Operations. Experienced candidates may be considered at the senior manager level.
• Prior pharmaceutical experience required. Cell therapy manufacturing experience a plus.
• Strong understanding of FDA, EMA, and ICH regulations for biologics/cell therapy manufacturing.
• Demonstrated ability to build strong relationships, resolve complex issues, and influence cross-functional stakeholders.
• Effective organization and prioritization skills, with the ability to work with aggressive timeframes and adhere to project deadlines in a fast-paced environment.

Responsibilities

• Serve as QA floor presence during manufacturing operations to provide real-time guidance, issue resolution, and batch record review.
• Ensure production activities are executed in compliance with cGMP, aseptic technique, and company SOPs.
• Support review and approval of batch records, logbooks, deviations, CAPAs, and change controls.
• Partner with cross-functional teams to ensure manufacturing suites, cleanrooms, and critical utilities remain in qualified state.
• Provide QA oversight of equipment qualification, calibration, and preventative maintenance programs.
• Review and approve environmental monitoring data, investigate excursions, and ensure timely resolution of facility, manufacturing and QC related deviations.
• Oversee compliance with aseptic process simulations (APS), gowning qualifications, and cleaning/disinfection programs.
• Ensure raw material release processes meet requirements, including supplier quality documentation and risk assessments.
• Participate in audit and inspection readiness activities; host and support regulatory inspections as QA representative.
• Champion a culture of quality and continuous improvement.

Benefits

• 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.
• Annual bonus based on company goals.
• Equity (RSU) grant.
• Relocation assistance for roles if required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees