Quality Systems & Compliance Engineer

Job Description

Multiply Labs is a robotics company on a mission to solve a significant bottleneck in modern medicine:
the manufacturing of life‑saving advanced biologics, from gene and cell therapies to antibodies and more.

Today, these therapies are produced through manual, labor‑intensive processes. Costs are extremely high—often $500K–$2M per patient—limiting access to only a small fraction of those who need them.

As product complexity increases and the cost of failure and scientific labor rises, the industry is shifting toward automation. Robotics and AI are making automated biologics manufacturing feasible, reliable, and economically scalable.

We believe the future of biomanufacturing is robotic—closed, automated, and scalable—ensuring critical therapeutics are accessible to every patient who needs them.

We don’t just build robots—we’re building the essential infrastructure for next generation biologics. Our technology enables biopharma companies to scale production without redesigning their science, reducing regulatory hurdles and lowering costs so these treatments can reach more patients.

• The Mission:
  Build the world’s best robots to make life-saving therapies accessible to all.
• The Technology:
  Advanced robotic orchestration, high-precision automation, cloud-integrated hardware-software systems, dextrous manipulation, and imitation learning.
• The
  
  Location:
  
  Headquartered in San Francisco, CA.
• The Backing:
  Supported by premier investors, including Casdin Capital, Lux Capital, and Y Combinator.

The Staff Quality Systems & Compliance Engineer is a foundational role within MLI’s Quality organization, owning the infrastructure that keeps our quality management system (QMS) running and our compliance posture inspection-ready. Reporting to the Head of Quality, this individual will be the operational owner of ZenQMS — MLI’s eQMS — and will lead day-to-day execution across all quality system programs including, but not limited to: document control, deviations/discrepancies, CAPA, change control, complaints, supplier quality, audits, data integrity, and management review.

This is a hands‑on, high‑ownership role for someone who thrives on building systems from scratch and making them stick in a fast‑moving, mission‑driven environment.

• Own configuration, administration, and continuous improvement of ZenQMS across all active and future modules.
• Train personnel on QMS processes including good documentation practices (GDP/ALCOA+), and ZenQMS workflows; serve as the internal subject matter expert for quality system tools.

• Manage the end‑to‑end NC/CAPA lifecycle
• Administer the Change Control program, reviewing proposed changes for quality and regulatory impact, coordinating cross‑functional approvals, and ensuring traceability.
• Maintain and report on key quality metrics: NC aging, CAPA on‑time closure rate, overdue change controls — escalating trends to the Head of Quality.

• Support MLI’s 21 CFR Part 11 and EU Annex 11 compliance posture— including audit trail reviews, access control oversight, and periodic data integrity assessments.
• Maintain and operationalize the Data Integrity Policy program, including DI risk mapping methodology and audit trail review schedules.
• Identify compliance gaps and drive remediation through the QMS; contribute to regulatory readiness and customer audit preparation.

• Plan, lead, and execute internal quality audits across MLI’s QMS programs, operations, and facilities; document findings and drive timely CAPA closure in ZenQMS.
• Conduct supplier audits…