Senior Director, Head of Quality & Responsible Person, International
Posted1 hour ago
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 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.
As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
For BridgeBio Full-Time U.S Based Roles:
Financial & Rewards
Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
Health & Well-Being
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family
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, & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
By applying, you acknowledge that BridgeBio will process your personal information as described in our Global Candidate Privacy Notice.
Find Jobs in Netherlands on Arbeitnow
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 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.
As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
For BridgeBio Full-Time U.S Based Roles:
Financial & Rewards
Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
Health & Well-Being
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family
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, & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
By applying, you acknowledge that BridgeBio will process your personal information as described in our Global Candidate Privacy Notice.
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