Sr. Mgr., Quality Management Systems
About The Position
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.
Requirements
- 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.
- Experience building, deploying and continuous improvement of a QRM program, facilitating cross-functional risk assessments, and applying fit for purpose methodologies (e.g. risk ranking and filtering, hazard analysis, FMEA, etc.) in a GxP-regulated environment.
- Working knowledge of applicable GxP regulations, and global regulatory expectations.
- Ability to lead cross-functional initiatives, and effectively communicate clear, risk-based quality guidance.
- Ability to manage multiple priorities and make sound decisions when working with incomplete information or changing business needs.
- Hands-on experience with Veeva Vault Quality applications, including QualityDocs, Training, and QMS, and supporting Document Control and GxP Training processes.
- Experience with Computer System Validation, including risk-based validation and lifecycle approaches for GxP computerized systems.
- Experience with APQR/PQR activities, QRM metrics, or Management Review reporting.
Responsibilities
- 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.
- 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.
- Oversee assigned QMS workflows, author or revise quality procedures, monitor KPIs, and implement improvements that promote compliance, efficiency, and scalability.
- Maintain audit-ready QMS documentation and records and support audit and inspection preparation, responses, and finding closure.
- Collaborate across GMP, Clinical, CMC, Regulatory, Supply Chain, and other functions to promote quality culture and provide practical, risk-based guidance.
- Support eQMS administration and optimization
- Partner with IT to resolve issues and implement improvements
- Provide Quality oversight or support for risk-based validation and lifecycle management of GxP computerized systems, as assigned.
Benefits
- 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
- 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
- Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
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What This Job Offers
Job Type
Full-time
Career Level
Senior
