Director/Sr. Director, Vendor Quality Management at BridgeBio Pharma

, , United States -

Full Time

Start Date

Immediate

Expiry Date

29 May, 26

Salary

2.0

Posted On

28 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Vendor Qualification, Lifecycle Management, Risk-Based Vendor Qualification, Vendor Risk Classification, Vendor Assessments, Quality Metrics, Quality Agreements, Performance Monitoring, Risk Management, Inspection Readiness, Regulatory Support, Cross-Functional Collaboration, Continuous Improvement, cGMP Knowledge, Global Regulatory Expectations, Vendor Audit Programs

Industry

Biotechnology Research

Description

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. COMPANY OVERVIEW 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. WHAT YOU’LL DO 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. 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 WHERE YOU’LL WORK This is a U.S.-based remote role with periodic travel to the San Francisco offices and global vendors and partners as needed. WHO YOU ARE • 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% Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial 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 Health & Wellbeing: 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 Skill Development & Career Paths: 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 At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary $1—$2 USD

Responsibilities

This role provides strategic and operational leadership for qualifying, overseeing, and managing the performance of contract manufacturers, laboratories, suppliers, and service providers supporting GxP activities. Key duties include establishing risk-based qualification programs, overseeing Quality Agreements, monitoring performance metrics, and ensuring inspection readiness.