Director/Sr. Director, Vendor Quality Management
About The Position
QED Therapeutics, an affiliate within BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasia, particularly Achondroplasia. Achondroplasia is the most common form of genetically driven short stature and can cause potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option for children living with Achondroplasia and their families. 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.
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
Responsibilities
- 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
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
- People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
- We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
- We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Director
