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. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
What You’ll Do
The Sr Director, Head of Quality & Responsible Person, International, leads quality for infigratinib, and will be the designated Responsible Person on the entity's wholesale distribution authorisation. The role reports to the Head of Quality, QED, with a dotted line to local managing director, and is based in the Netherlands. If the entity becomes the marketing authorisation holder for infigratinib, the role also covers the related MAH quality duties. The role holds an unrestricted right of escalation to the entity's full board and is independent of commercial operations and of manufacturing/supply with EU-GDP guidelines, relevant EU directives (including the Falsified Medicines Directive), Dutch Medicines Act, and public service requirements. This role acts as a QA liaison of BridgeBio's contract service providers (CSPs), providing oversight of lot release activities. This role includes reviewing and approving batch records, certificates of analysis, and compliance documents, providing quality review of deviations, change controls, and CAPAs related to assigned CSPs, collaborating closely with CSPs and internal teams such as quality control, manufacturing, regulatory affairs, and supply chain. The role builds and leads a small quality team (deputy RP, QA compliance/QMS, QA operations/GDP), owns the quality management system across the Skeletal Dysplasia assets, and leads WDA licensing, inspection readiness and potentially subsequent MIA readiness, if needed in the future.
Responsibilities
Major Responsibilities / Accountabilities
Serve as the named Responsible Person on the WDA: release for distribution, recall decisions, and GDP compliance of the entity
Leads and develops the entity's quality team: deputy RP, QA compliance/QMS, and QA operations/GDP; and QP
Manages and improves the Quality Management System (QMS) across the entity's assets in alignment with the established QMS
Lead the WDA application and IGJ inspection readiness; prepare subsequent MIA readiness (QP recruitment, import and batch-certification processes)
Own the quality agreement matrix: includes Quality oversight of contract service providers, 3PLs, distributors and intercompany interfaces
Act as a Quality liaison and provide oversight and quality support of assigned contract service providers
Perform quality review of assigned quality events such as deviations, change controls, supplier notifications
Review master manufacturing batch records, including related documents such as specifications, analytical and microbiological methods, stability study protocols, and label proofs
Manage lot release activities and communication of lot release schedules to key stakeholders
Communicate manufacturing deficiencies/non-conformances to management and work with CSPs to ensure timely resolution
Review process and method validation protocols and reports
Review analytical test results to ensure compliance with approved specifications
Assist in…