Director/Sr. Director, Vendor Quality Management

Role Summary

Director/Sr. Director, Vendor Quality Management provides strategic and operational leadership for the qualification, oversight, and performance management of contract manufacturers, contract laboratories, suppliers, and service providers supporting GxP activities. The role leads vendor qualification lifecycle, governance, and risk management to ensure compliant, high-quality external manufacturing and testing across programs. It reports to the Vice President, Quality, and collaborates with CMC, Clinical Operations, Regulatory, Supply Chain, Commercial, Legal and other functions. This is a U.S.-based remote role with quarterly visits to the San Francisco, CA office.

Responsibilities

• Vendor Qualification & Lifecycle Management
  • Establish and maintain a risk-based vendor qualification and requalification program
  • Define vendor risk classification criteria and oversight frequency
  • Oversee vendor assessments and approval processes
  • Monitor vendor performance through quality metrics
  • Lead vendor transition or discontinuation activities as needed
• Quality Agreements & Governance
  • Oversee development and maintenance of Quality Agreements
  • Ensure agreements clearly define roles and responsibilities
  • Align Quality Agreements with business contracts
  • Periodically review and update agreements
• Performance Monitoring & Risk Management
  • Establish vendor performance metrics
  • Conduct Quality Business Reviews with key vendors
  • Implement risk-based monitoring strategies
  • Proactively identify and mitigate compliance risks
• Inspection Readiness & Regulatory Support
  • Ensure vendor oversight documentation supports inspection readiness
  • Participate in regulatory inspections
  • Coordinate vendor support during inspections
  • Oversee remediation related to vendor findings
• Cross-Functional Collaboration
  • Partner with CMC, Clinical Operations, Clinical Development, Supply Chain, Commercial, Regulatory, Legal and other functions as needed
  • Provide vendor compliance risk expertise during program planning
  • Support new product introductions and technology transfers as needed
• Continuous Improvement
  • Benchmark vendor oversight practices
  • Drive digital enablement of vendor management systems
  • Promote proactive quality culture across partner network

Qualifications

• 12+ years of pharma/biotech quality experience with vendor oversight
• Strong knowledge of cGMP and global regulatory expectations
• Experience managing vendor audit programs
• Experience drafting and negotiating Quality Agreements
• Experience supporting regulatory inspections
• Strong risk assessment and collaboration skills

Education

• Bachelor’s degree in scientific discipline or equivalent experience

Skills

• Vendor quality management
• Risk assessment and mitigation
• Cross-functional collaboration
• Quality systems and metrics
• Negotiation and drafting of Quality Agreements
• Regulatory inspection support

Additional Requirements

• Travel: approximately 25–35%