[Hiring] Quality Lead @Serova

Role Description

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.

• 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

Qualifications

• 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