What You'll DoReporting to the Associate Director, Quality Management Systems, the Senior Manager, Quality Management Systems will lead the administration, governance, and continuous improvement of the company's Quality Risk Management (QRM) program and serve as a trained backup for Document Control and the GxP Training Program. This role partners closely with the Associate Director and cross-functional stakeholders to embed risk-based decision-making across GxP operations while ensuring assigned QMS processes are compliant, inspection-ready, effective, and scalable in alignment with global regulatory requirements and organizational objectives.
ResponsibilitiesQuality 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.
- Oversee assigned QMS workflows, author or revise quality procedures, monitor KPIs, and implement improvements that promote compliance, efficiency, and scalability.
Inspection Readiness & Cross Functional Collaboration
- 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.
Systems & Digital Quality Support
- 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.
Where You'll Work This a U.S.-based remote role that will require periodic travel to the San Francisco offices as needed.
Who You Are- 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.
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
$147,700-$176,500 USD
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
