Sr. Mgr., Quality Management Systems
BridgeBio Pharma · Remote
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Role summary
BridgeBio Pharma seeks a Senior Manager for Quality Management Systems to lead the development and governance of the company's Quality Risk Management program. Reporting to the Associate Director, this remote role will embed risk-based decision-making across GxP operations while ensuring compliance, inspection readiness, and continuous improvement across quality processes.
What they're looking for
- Experience leading Quality Risk Management programs in regulated pharmaceutical or biotech environments
- Deep knowledge of QRM methodologies such as FMEA, risk ranking, filtering, and hazard analysis
- Strong understanding of GxP compliance, global regulatory requirements, and inspection readiness standards
- Demonstrated expertise in quality systems administration, document control, and process improvement
- Cross-functional collaboration and stakeholder management skills across GMP, clinical, regulatory, and supply chain functions
- Ability to develop training materials, procedures, and audit-ready documentation
What you'll be doing
- Lead development, deployment, and continuous improvement of the Quality Risk Management program and associated tools
- Facilitate cross-functional risk assessments using fit-for-purpose methodologies and monitor mitigation activities
- Serve as trained backup for Document Control and GxP Training Program administration and compliance
- Maintain audit-ready QMS documentation and support regulatory inspection preparation and response
- Communicate QRM metrics and trends through Management Review and governance forums
Privacy & handoff
This role links to BridgeBio Pharma's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.