Director/Sr. Director, Vendor Quality Management

📋 Description

• • Are you a visionary leader with a passion for ensuring the highest quality standards in pharmaceutical development? BridgeBio Pharma, an innovative leader in pioneering a "moneyball for biotech" approach, is seeking a highly motivated and strategic Director/Sr. Director, Vendor Quality Management to join our dynamic team. This pivotal role is instrumental in our mission to develop life-changing medicines for patients with unmet needs, particularly focusing on rare diseases like FGFR-driven skeletal dysplasia through our affiliate, QED Therapeutics. If you thrive in an environment that challenges conventions, pushes boundaries, and empowers experts to solve complex problems, this is your opportunity to redefine the future of biopharma.
• • As the Director/Sr. Director, Vendor Quality Management, you will report directly to the Vice President of Quality and will be responsible for providing strategic and operational leadership across the entire lifecycle of our external partnerships. This includes the meticulous qualification, rigorous oversight, and proactive performance management of all contract manufacturers (CMOs), contract laboratories, suppliers, and other service providers critical to our GxP (Good Practice) activities. Your expertise will be crucial in maintaining the integrity and compliance of our supply chain and development processes, ensuring that every partner uphns the stringent quality standards required for patient safety and therapeutic efficacy.
• • Your responsibilities will encompass establishing and maintaining a robust, risk-based vendor qualification and requalification program. You will define clear criteria for vendor risk classification and determine appropriate oversight frequencies, ensuring that resources are allocated effectively based on potential impact. This involves overseeing comprehensive vendor assessments and approval processes, meticulously documenting each step to ensure transparency and accountability. A key aspect of your role will be to continuously monitor vendor performance through the establishment and tracking of key quality metrics, identifying trends and areas for improvement.
• • Furthermore, you will play a central role in managing the lifecycle of our vendor relationships, including leading transition or discontinuation activities when necessary, always with a focus on minimizing disruption and maintaining quality. You will oversee the development and maintenance of comprehensive Quality Agreements, ensuring that these critical documents clearly define the roles, responsibilities, and expectations of all parties involved. Aligning these Quality Agreements with overarching business contracts will be essential to ensure seamless integration and operational efficiency. Regular review and updates of these agreements will be necessary to reflect evolving project needs and regulatory landscapes.
• • Proactive performance monitoring and risk management are at the core of this role. You will establish and implement vendor performance metrics that provide actionable insights into partner capabilities and compliance. Conducting regular Quality Business Reviews (QBRs) with key vendors will be a primary method for fostering collaboration, addressing challenges, and ensuring continuous alignment. You will implement risk-based monitoring strategies to identify potential compliance issues before they escalate, proactively mitigating risks to protect our programs and patients. Your vigilance will be key to maintaining a compliant and high-performing external network.
• • Ensuring inspection readiness and providing robust regulatory support are paramount. You will ensure that all vendor oversight documentation is meticulously maintained and readily available to support regulatory inspections. Your participation in regulatory inspections, and your coordination of vendor support during these critical events, will be vital. You will also oversee the remediation efforts related to any findings identified during inspections, ensuring that corrective actions are effectively implemented and sustained.
• • Cross-functional collaboration is essential for success. You will partner closely with various internal departments, including CMC (Chemistry, Manufacturing, and Controls), Clinical Operations, Clinical Development, Supply Chain, Commercial, Regulatory Affairs, Legal, and others as needed. Your expertise in vendor compliance risk will be invaluable during program planning, and you will support new product introductions and technology transfers, ensuring that external partners meet all quality requirements.
• • Finally, you will be a champion for continuous improvement within our vendor management framework. You will benchmark our vendor oversight practices against industry best practices, identify opportunities for innovation, and drive the digital enablement of our vendor management systems. Your efforts will promote a proactive quality culture that extends across our entire partner network, fostering a shared commitment to excellence and patient well-being. This role offers a unique opportunity to shape the quality strategy for a rapidly growing and impactful biopharmaceutical company.