Staff Quality Systems & Compliance Engineer
Multiply Labs
- Pay
- $140K to $185K
- a year
- Location
- San Francisco, United States
- Work style
- On-site
- Job type
- Full time
- Posted
- Sep 30
- 20 days ago
Career path
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About the company
Multiply Labs
Industrial automation · 11 to 50 employees
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.
What you need
- Bachelor’s degree in Life Sciences, Engineering, Chemistry, or a related field. 6-8 years of quality systems or GxP compliance experience in CGT, biopharma, medical device, or contract development/manufacturing. Demonstrated hands-on experience administering an eQMS platform (ZenQMS, Veeva, MasterControl, or equivalent) Strong working knowledge of 21 CFR Part 11, EU Annex 11, ALCOA+, and GDocP principles. Experience conducting internal and/or supplier audits in a regulated GxP environment; familiarity with ISO 9001, ISO13485 or ISO 19011. Experience hosting or supporting external audits or regulatory inspections (customer audits, FDA, EMA, Notified Body, or equivalent). Experience owning quality program execution — not just supporting it — in a small or fast-moving team environment. Excellent technical writing and documentation skills with meticulous attention to detail. Comfortable operating with autonomy and building process where limited infrastructure exists.
- Direct experience with eQMS configuration and administration. Lead auditor certification (ISO 9001, ISO 13485, or equivalent). Background in equipment or software validation (IQ/OQ/PQ, CSV) in a GMP setting. Familiarity with robotic or automated manufacturing systems and associated quality challenges. ASQ CQA, CQE, or equivalent quality certification. Prior experience in a start-up or scale-up biotech company; comfort with ambiguity and rapid iteration.
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