高级经理，质量管理系统
Sr. Mgr., Quality Management Systems
渴望变革者
你上一次实现不可能的事情是什么时候？如果这个想法让你感到压力山大，你可能想在这里停下来，但如果它让你兴奋……继续读下去吧
2015年，我们开创了“生物技术版金钱棒”方法，将学术界的项目和有前景的早期研究整合到一个财务框架下，以降低风险并激发创新。这种模式让科学和小型专家团队引领方向。我们搭建桥梁，推动罕见病领域的突破性进展，并尽可能快速地为有未满足需求的患者开发改变生命的药物。
我们共同定义空白领域，突破边界，赋能人们解决问题。如果你是一个不拘一格的人，加入我们，与业内最受尊敬的专家之一并肩工作。我们一起提出“为什么不？”并帮助重塑生物制药的未来。在BridgeBio，我们重视好奇心和实验——包括对AI的伦理且审慎的使用，以提高工作的清晰度、速度和质量。
你将负责
向质量管理系统副经理汇报，高级经理将领导公司质量风险管理（QRM）计划的管理、治理和持续改进，并作为文件控制和GxP培训计划的受训后备人员。此职位与副经理及跨职能利益相关者紧密合作，将基于风险的决策嵌入GxP运营，同时确保指定的QMS流程符合要求，能够接受检查，有效且可扩展，符合全球监管要求和组织目标。
职责
质量风险管理计划领导
- 领导QRM计划的开发、实施和持续改进，包括程序、模板、工具和风险登记册。
- 使用适当的方法进行跨职能风险评估，包括适合用途的工具（如风险排序和筛选、危害分析、FMEA）。
- 确保风险评估明确风险负责人、缓解措施、截止日期、剩余风险决定和审查要求；监控缓解活动并升级重大或逾期的风险。
- 将QRM原则整合到适用的流程中，并通过管理评审和其他治理论坛传达QRM指标和趋势。
- 提供QRM指导和培训，保持可接受检查的文档，并
查看英文原文
Mavericks Wanted
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 on
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.
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 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
Originally posted on Himalayas