Director/Sr. Director, Vendor Quality Management

Role Overview

• Reporting to the Vice President, Quality, the Director/Sr. Director, Vendor Quality Management provides strategic and operational leadership for the qualification, oversight, and performance management of contract manufacturers (CMOs), contract laboratories, suppliers, and service providers supporting GxP activities.
• 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
• 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
• Establish vendor performance metrics
• Conduct Quality Business Reviews with key vendors
• Implement risk-based monitoring strategies
• Proactively identify and mitigate compliance risks
• Ensure vendor oversight documentation supports inspection readiness
• Participate in regulatory inspections
• Coordinate vendor support during inspections
• Oversee remediation related to vendor findings
• 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
• Benchmark vendor oversight practices
• Drive digital enablement of vendor management systems
• Promote proactive quality culture across partner network

Requirements

• Bachelor’s degree in scientific discipline or equivalent experience
• 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
• Travel: ~25–35%

Benefits

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered
• no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model
• employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off
• take the time that you need
• Paid parental leave
• 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability
• Subsidized lunch via Forkable on days worked from our office