Sr. Mgr., Quality Management Systems New Remote - USA

BridgeBio Inc.; Northern (KY); Hybrid; USD 148,000 - 177,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Pre-tax commuter benefits

Job summary

BridgeBio Inc. is seeking a Senior Manager, Quality Management Systems to lead the QRM program and ensure regulatory-ready quality processes. You will partner across GMP, Clinical, Regulatory, and Supply Chain to embed risk-based decision-making and maintain inspection-ready documentation.

The role requires 7+ years in QA within biotech/pharma, experience with Veeva Vault QMS, and strong regulatory knowledge. Remote US-based with periodic travel to San Francisco offices.

Qualifications

• Bachelor’s degree in scientific or technical discipline.
• Minimum 7 years of QA or related experience in pharma/biotech.
• Experience building, deploying, and continuously improving a QRM program.

Responsibilities

• Lead the development and governance of the QRM program.
• Back up Document Control and GxP Training activities.
• Collaborate with GMP, Regulatory, and other functions to drive quality.

Skills

Quality management

Cross-functional leadership

Regulatory knowledge

Risk-based decision making

Communication

Education

Bachelor's degree in scientific/technical discipline

Tools

Veeva Vault Quality

QualityDocs

QMS

Job description

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read onIn 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 allowsscience and small teams of experts to lead the way. We build bridges to groundbreaking advancements in raredisease, anddevelop 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'llask"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.

What You’ll Do

Reporting 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.

Responsibilities

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 elevate 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.

$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:

• 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
• HealthSavings 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, continuouseducationand professional development programs via LinkedIn Learning,LifeLabs, &BetterUpCoaching
• We celebratestrong performancewith financial rewards, peer-to-peer recognition, and growth opportunities