GxP Quality Lead – Biotech (Remote w/ Site Visits)

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

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