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Quality lead

Serova

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Design novel cancer vaccines.

$15.0M venture funding raised· Backed by Foresite Capital Management, The Column Group
FULL TIMERemote · United StatesRemote · United Kingdom4 employeesPosted Oct 6
gxp quality management systemsop developmentdocument controlcapachange controlvendor qualificationcdmo managementbatch releaseclinical qualitygcpgmpdata integritycomputerized systemsai-enabled workflowsauditingregulatory inspection readiness

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About Serova

Serova builds personalized cancer vaccines. Each vaccine is made for the individual patient from their own samples and given in partnership with their treating physician. We're building a lab, a manufacturing facility and a clinic at the same time, and every batch we make is for a single patient.

The role

We're building a lab, a manufacturing facility and a clinic, and all of them need a quality system. You'll build a fit-for-stage GxP quality management system across them and keep it working as we grow.

What you'll do

  • Build and mature our GxP quality management system: SOPs, document control and training records

  • Run deviations, CAPAs and change control

  • Qualify vendors and CDMOs and put quality agreements in place, including with our manufacturing partners

  • Set up the batch release process for patient-specific product

  • Provide quality oversight across product development, manufacturing, expanded access and clinical work

  • Plan audits of sites and vendors, and get us inspection-ready, including our Bozeman clinic

  • Set quality rules for our digital systems, automation, data integrity and AI-enabled workflows, built so they don't slow us down

  • Own change control for our in-house software and analysis pipeline, which updates often

Who you are

  • A hands-on quality lead who builds proportionate, risk-based systems from the ground up

  • You would never import a big-pharma QMS wholesale

  • Comfortable with both the framework and the detail

  • High agency, friendly and low ego

Requirements

  • Hands-on clinical quality (GCP) experience, not only GMP, plus a working knowledge of GMP

  • You've run audits, investigations, CAPAs and change control

  • Based in the San Francisco Bay Area or London, or remote with regular site visits

  • Authorized to work in the US or UK, or a realistic path to get there

What will make you stand out

  • You've built a QMS at an early-stage biotechnology company

  • Quality for digital and automated systems: data integrity, computerized systems, AI-enabled workflows

  • Biologics, advanced therapies or oncology

  • Vendor and CDMO qualification, quality agreements, batch release

  • Multi-site clinical quality, including site readiness and inspections

Details

  • Location: San Francisco or London, or remote with site visits

  • Type: Full-time

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