Quality lead
serovaMillbrae (CA)
About the role
About SerovaSerova 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 outYou'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
DetailsLocation: San Francisco or London, or remote with site visits
Type: Full-time
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
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Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
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