Quality lead

Serova; San Francisco (CA); Remote; USD 150,000 - 210,000; Full time

Job summary

Serova is building a lab, manufacturing facility and clinic and seeks a hands-on quality lead to build a fit-for-stage GxP quality management system across our operations. You will design and implement SOPs, document control and training records to enable scale while maintaining patient safety and data integrity.

In this role you will drive deviations, CAPAs and change control, qualify vendors and CDMOs, set up batch release for patient-specific products, and prepare sites for inspections across

Qualifications

• H ands-on clinical quality (GCP) experience, plus working knowledge of GMP
• Experience running 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

Responsibilities

• Build and mature our GxP quality management system across lab, manufacturing and clinic
• Run deviations, CAPAs and change control processes
• Qualify vendors and CDMOs and establish quality agreements with manufacturing partners
• Set up the batch release process for patient-specific products
• Provide quality oversight across product development, manufacturing and clinical work
• Plan audits of sites and vendors and prepare for inspections
• Set quality rules for digital systems, automation, data integrity and AI-enabled workflows
• Own change control for in-house software and analysis pipelines

Skills

GxP Quality Management

SOPs & Documentation

CAPA & Change Control

Vendor/CDMO Qualification

Batch Release

Audit Readiness & Inspections

GCP & GMP knowledge

Data Integrity & Digital Systems

Risk-based Quality System

Job description

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