Senior Director, Head of Quality & Responsible Person, International

The role

The Senior Director, Head of Quality & Responsible Person, International leads quality for infigratinib and serves as the designated Responsible Person for the entity's wholesale distribution authorisation. This role manages the quality management system, leads a small quality team, and provides oversight of contract service providers.

What you will do

• Serve as the named Responsible Person on the WDA
• Leads and develops the entity's quality team
• Manages and improves the Quality Management System (QMS)
• Lead the WDA application and IGJ inspection readiness
• Own the quality agreement matrix
• Act as a Quality liaison and provide oversight of contract service providers
• Perform quality review of deviations, change controls, and supplier notifications
• Review master manufacturing batch records and related documents
• Manage lot release activities
• Communicate manufacturing deficiencies to management

Required qualifications

• BS/MS degree
• 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
• Experience leading regulatory inspections with EU competent authorities
• 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
• Understanding of the EU and particularly IGJ regulations in relation to the wholesale distribution of medicines
• Proficiency in document and presentation office tools (Microsoft Office, Google Docs, etc.)

Nice to have

• prior appointment as (or eligibility to be) a Responsible Person
• IGJ preferred

Benefits

• Market leading compensation
• Hybrid work model
• Career development through regular feedback, continuous education and professional development programs
• Financial rewards, peer-to-peer recognition, and growth opportunities

About the company

BridgeBio builds bridges to groundbreaking advancements in rare disease and develops life-changing medicines for patients with unmet needs. The company uses a moneyball for biotech approach to reduce risk and unleash innovation.