Quality Director Responsible Person - Head of Quality, International

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 updating CMC sections of regulatory and quality documents
• Participate in internal and external project team meetings

Other QA/Responsible Person related responsibilities

• Ensure accuracy of quality of records per GDP requirements including GDPs are implemented and maintained in the quality management system requirements for WDA license
• Support and coordinate return, rejected, falsified products, recall operations of medicinal products
• Provide oversight of GDP and GMP activities of active pharmaceutical ingredients (API)
• Ensure WDA and API registration is current with commercial supply chain
• Participate and leads EU/ROW regulatory inspections
• Participate and oversee GMP vendor qualification program
• Oversee the EU/ROW internal audit program, internal training program and ensure data integrity
• Write and review governing procedures as needed (e.g., SOPs, WIs, etc.)
• Other duties as assigned

Where You’ll Work 

• This is a Netherlands based remote role
• Travel 30% of time is expected

Who you are

• BS/MS degree preferably in operations, science, pharmacy
• A diploma, certificate, or other evidence of formal qualifications on completion of GDP/GDP-API training required for registration as an RP by the competent authorities in the Netherlands
• 10+ years in pharmaceutical quality, including significant GDP / distribution quality experience; prior appointment as (or eligibility to be) a Responsible Person strongly preferred
• Experience leading regulatory inspections with EU competent authorities (IGJ preferred)
• Prior experience of managing third party vendors (CMOs, CTLs, 3PLs, etc.)
• Prior relevant knowledge and experience related to the distribution of medical products
• Strong understanding of supply chain concepts, supplier management, inventory management
• Extensive knowledge of US/EU GMPs /GDPs and associated guidance
• Working in a highly regulated environment
• Proven leadership of quality teams; experience building quality functions or systems
• Understanding the EU and particularly IGJ regulations in relation to the wholesale distribution of medicines
• Strong planning and time management skills with ability to prioritize workload
• Excellent analytical and problem-solving skills, with keen attention to detail
• Proficiency in document and presentation office tools (Microsoft Office, Google Docs, etc.)
• Basic understanding of data concepts and enterprise resource planning (ERP) systems e.g., SAP
• Ready to embrace company core values and diverse corporate culture

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.

• Market leading compensation
• Hybrid work model - we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community
• We provide career development through regular feedback, continuous education and professional development programs
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.