Senior QA Manager, GMP GxP Auditing & Vendor Management

Scorpion Therapeutics; California (MO); On-site; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Lead GxP vendor and supplier quality management expert to oversee GMP/GxP audits for a late-stage oncology biopharma. You will manage audit schedules, ensure regulatory compliance, and draft Quality Technical Agreements with suppliers.

The role requires extensive auditing experience, ASQ QA credentials, and strong leadership and negotiation skills, with up to 25% travel to sites and vendors.

Qualifications

• BA/BS in Biological Sciences, Chemistry or related field.
• 8+ years in pharma/biotech, including 5+ years as GMP Lead Auditor.
• Extensive experience with QTA and supplier quality management.
• ASQ Certified Quality Auditor or equivalent.
• Strong communication, leadership, and negotiation skills.
• Ability to travel up to 25%.

Responsibilities

• Conduct internal and external GMP/GxP audits.
• Maintain audit schedules and ensure regulatory compliance.
• Draft and negotiate Quality Technical Agreements (QTA).
• Perform risk assessments and monitor supplier qualifications; lead audit inspections.
• Collaborate with cross-functional teams and external vendors to uphold quality standards, improve compliance processes, and support supplier performance metrics.
• Prepare audit reports and track KPIs.

Skills

GxP knowledge

GMP audits

Audit leadership

Vendor management

Negotiation

Communication

Education

BA/BS in Biological Sciences, Chemistry or related field

Tools

Quality Technical Agreements (QTA)

Job description

Role

Lead GxP vendor and supplier quality management for a late-stage oncology biopharma developing RAS pathway inhibitors.

Responsibilities

• conduct internal and external GMP/GxP audits
• maintain audit schedules
• ensure compliance with regulations
• draft and negotiate Quality Technical Agreements
• perform risk assessments
• monitor supplier qualifications
• lead audit-related inspections
• Collaborate with cross-functional teams and external vendors to uphold quality standards, improve compliance processes, and support supplier performance metrics.
• Prepare audit reports, manage supplier qualification processes, and track KPIs.

Requirements

• BA/BS in Biological Sciences, Chemistry or related field
• 8+ years in pharma/biotech, including 5+ years as GMP Lead Auditor
• extensive experience with QTA and supplier quality management
• ASQ Certified Quality Auditor or equivalent
• strong communication, leadership, and negotiation skills
• ability to travel up to 25%

Preferred

• experience drafting Quality Agreements
• vendor qualification
• risk assessment
• audit analysis

High-Value

• GxP compliance
• GMP audits
• supplier qualification
• risk management
• in a biologics or small molecule context
• supporting regulatory inspections and supplier oversight