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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
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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
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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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