Director/Sr. Director, Vendor Quality Management
BridgeBio
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $1 - $2 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
vendor qualificationrisk assessmentvendor performance managementquality metricsquality agreementsregulatory inspectionsaudit programscompliance risk managementdigital enablementGxP activities
Soft Skills
strategic leadershipoperational leadershipcollaborationcommunicationproblem-solvingproactive quality culturenegotiationrisk mitigationorganizational skillsstakeholder engagement