Sr. Mgr., Quality Management Systems

BridgeBio - United States

Hiring: Sr. Mgr., Quality Management Systems Company: BridgeBio Location: United States Job Posted Time: 2026-09-16 22:47:39 Employment Type: Full-time / Remote Target Skills & Keywords : Quality Assurance, Risk Management, Vault About the job Experience: •7 years of progressive Quality Assurance or related experience in pharmaceutical or biotechnology industry. Required Skills: •Quality Risk Management Program Leadership •Lead the development, deployment, and continuous improvement of the QRM program, including procedures, templates, tools, and risk registers. •Facilitate cross-functional risk assessments using appropriate methodologies, including fit-for-purpose tools (e.g. risk ranking and filtering, hazard analysis, FMEA). •Ensure risk assessments define risk owners, mitigation actions, due dates, residual-risk decisions, and review requirements; monitor mitigation activities and escalate significant or overdue risks. •Integrate QRM principles into applicable processes and communicate QRM metrics and trends through Management Review and other governance forums. •Provide QRM guidance and training, maintain inspection-ready documentation, and support audits and regulatory inspections. •QMS Operations & Process Support •Serve as a trained backup for Document Control and GxP Training activities, including controlled-document workflows, training assignments, compliance monitoring, and maintenance of inspection-ready records. Qualifications: •Bachelor's degree in scientific or technical discipline, or equivalent relevant experience. •Minimum of 7 years of progressive Quality Assurance or related experience in pharmaceutical or biotechnology industry. •Solid functional working knowledge of applicable GxP regulations, and global regulatory expectations. •Demonstrated capacity to lead cross-functional initiatives, and effectively communicate clear, risk-based quality guidance. •Demonstrated capacity to manage multiple priorities and make sound decisions when working with incomplete information or changing business needs. •Applied hands-on capability in Veeva Vault Quality applications, including QualityDocs, Training, and QMS, and supporting Document Control and GxP Training processes. Compensation: •$147,700 - $176,500 / year •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!