Senior GxP QA & Vendor Compliance Lead (Remote)

Regulatory Jobs; Redwood City (CA); On-site; USD 164,000 - 205,000; Full time

Job summary

Revolution Medicines in Redwood City is seeking an experienced Lead Auditor to drive GxP compliance and supplier quality programs, conducting internal and external audits and leading corrective action follow-ups across the organization.

The role requires coordinating audit schedules, drafting quality agreements, performing risk assessments, and ensuring GMP/GxP compliance with suppliers. Travel up to 25% and strong leadership skills are essential.

Qualifications

• BA/BS degree in Biological Sciences, Chemistry, or related field.
• Minimum 8+ years pharmaceutical/biotech experience with at least 5+ years GMP Lead Auditor experience.
• 5 years of QTA and Supplier Quality Management experience.
• ASQ Certified Quality Auditor or equivalent certifications.
• Excellent leadership and people management/development skills.
• Experience with Quality System electronic databases.
• Strong written and oral communication and negotiation skills.
• Ability to travel occasionally (up to 25%).

Responsibilities

• Lead GxP internal audits and external audits including audit reports and corrective actions.
• Maintain internal/external audit schedules and ensure follow-up.
• Assure GMP/GxP compliance with suppliers.
• Oversee vendor/supplier program management for GxP compliance.
• Draft and implement Quality Agreements with vendors and partners.
• Perform risk assessments, qualifications, and monitor suppliers/CMOs.
• Collaborate with cross-functional teams and represent Quality Vendor Management in meetings.
• Develop tools to improve compliance, consistency, and efficiency for GMP/GxP auditing and vendor management.
• Support regulatory inspections and partner audits with cross-functional teams.
• Maintain approved GxP supplier list and annual audit schedules.

Skills

Leadership

Communication

Negotiation

Travel readiness

Education

BA/BS in Biological Sciences, Chemistry, or related field

Tools

Microsoft Office

Quality databases

Job description

Revolution Medicines in Redwood City is seeking an experienced Lead Auditor to drive GxP compliance and supplier quality programs, conducting internal and external audits and leading corrective action follow-ups across the organization.

The role requires coordinating audit schedules, drafting quality agreements, performing risk assessments, and ensuring GMP/GxP compliance with suppliers. Travel up to 25% and strong leadership skills are essential.