Senior Manager, Quality Assurance Compliance

Summary

Join BridgeBio as a Quality Assurance Compliance Manager and manage global Quality Agreements with external stakeholders, ensuring compliance with all terms and conditions, regulatory requirements, and internal standards. Collaborate with internal and external teams to bring Quality Agreements to an approvable state and coordinate regulatory authority inspection readiness activities. Participate in vendor qualification, internal and external audits, and ensure compliance with audit findings. Identify and assess compliance risks, develop mitigation strategies, and support the development of quality metric reports. This Netherlands-based remote role requires quarterly visits to Amsterdam or Zug. The position reports to the Director, QA Compliance and provides global audit and compliance oversight at BridgeBio Affiliates and contract service providers.

Requirements

• Bachelor’s degree or equivalent in science, mathematics, or engineering
• A minimum of 8 years of experience working in a Biotech or Pharmaceutical FDA-regulated industry in QA or a related field, or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained
• Working knowledge of cGMPs (CFR/ICH/EMA) and applicable international regulations/ guidance
• Experience reviewing audit reports, quality agreements, and procedures
• Prior experience with a commercial product
• Prior experience in supporting PAI and regulatory inspection readiness
• Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
• Strong planning and time management skills with the 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
• Ready to embrace companies’ core values and diverse corporate culture
• Eligible to work in The Netherlands

Responsibilities

• Manage global Quality Agreements with external stakeholders (e.g., contract service providers), ensuring compliance with all terms and conditions, regulatory requirements, and internal standards
• Collaborate with internal cross-functional teams and external stakeholders to bring Quality Agreements to an approvable state
• Coordinate regulatory authority inspection readiness activities at CSP and internally
• Participate in the global supply chain vendor qualification process to ensure compliance with regulatory and internal standards
• Participate in the planning and conduct of internal audits, and support external audits
• Ensure audit findings are followed up, corrective actions are completed, implemented, and verified to ensure compliance
• Identify and assess risks to compliance, develop mitigation strategies, and ensure effective implementation
• Support the development of meaningful quality metric reports or dashboards related to inspections or audits
• Participate in hosting regulatory inspections
• Assist in the creation and revision of applicable procedures
• Perform other duties as assigned, including high-level responsibilities and day-to-day activities
• Stay informed of relevant regulations and standards and ensure compliance with applicable requirements

Preferred Qualifications

Prefer experience in oversight of external vendors

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Commitment to Diversity, Equity & Inclusion