--- title: 'Manager, Quality Systems and Risk Management at BridgeBio Pharma' canonical: 'https://feeny.ai/job/manager-quality-systems-and-risk-management-bridgebio-pharma-united-states-z8xc0ve828fx' type: 'job' last_seen: '2026-09-16' --- # Manager, Quality Systems and Risk Management at BridgeBio Pharma - **Company:** BridgeBio Pharma - **Location:** United States - **Compensation:** $126k–$153k - **Work type:** remote - **Posted:** 2026-07-08 - **Last confirmed live:** 2026-09-16 - **Apply:** https://job-boards.greenhouse.io/bridgebio/jobs/5179745007 ## Job description 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 The Quality Systems and Risk Management Manager reports to the Sr. Manager of Quality Systems Management and plays a key supporting role in the execution and continuous improvement of the organization's risk management program and Quality Management System (QMS). This individual contributes across two core areas: Owning and leading formal risk management through risk assessments, risk registers, and the application of ICH Q9 and FMEA frameworks, and Maintaining and improving the QMS. They also play a hands-on role in key quality processes such as Annual Product Quality Review (APQR) compilation and the generation of quality metrics for Quality Management Reviews (QMRs), working closely with the Sr. Manager to ensure compliance with GxP regulatory standards and company policies. The ideal candidate is detail-oriented, highly organized, and eager to develop deep expertise across quality systems in a commercial-stage biopharmaceutical environment and bring a collaborative mindset and the ability to work effectively across functions to support quality deliverables and timelines. ## Responsibilities - Own and drive formal risk management activities across the organization by leading risk assessments, maintaining risk registers, and applying risk frameworks such as ICH Q9 and FMEA. Integrate risk-based thinking into day-to-day QMS activities and serve as the subject matter expert for risk management methodology. - Support the maintenance and continuous improvement of the QMS. Participate in QMS improvement initiatives, including the onboarding and implementation of new Veeva Vault QMS modules, and serve as the procedural subject matter expert for assigned QMS processes, maintaining the associated documentation to reflect current practice and regulatory expectations. - Manage the preparation and compilation of APQR reports. Play a hands-on role in the APQR process by supporting cross-functional data collection, compiling product review data accurately and thoroughly, and helping ensure timely completion and approval of APQR reports. Escalate potential trends and product quality or regulatory compliance issues to management - Assist in the generation of Quality metrics and Key Performance Indicators (KPIs) for Quality Management Reviews (QMRs) etc. Analyze and present quality data to identify trends, risks, and opportunities for improvement. Collaborate with internal and external key stakeholders for compilation of quality metrics, APQR, etc. - Assist in executing process improvement initiatives using Lean Six Sigma principles, including data gathering, root cause analysis support, and CAPA follow-through. Contribute to improvement projects aimed at reducing cycle times and enhancing quality system efficiency, and apply Lean Six Sigma tools as part of ongoing quality work. - Participate in audits and regulatory inspections. - Ensure all activities comply with current GxP regulatory standards and internal procedures. - Establish work priorities to meet targets and timelines and effectively manage competing priorities with minimal escalations. - Assist in preparation, review and revision of Standard Operating Procedures (SOPs), as required. - Other duties as assigned Where You'll Work This is a remote/hybrid role that may require visits to our San Francisco Office. ## Who You Are - Bachelor’s degree or equivalent in pharmacy, science, mathematics or engineering required - A minimum of 8 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained - Strong experience and knowledge leading formal risk management activities in a GxP environment, including risk identification, assessment, and mitigation using tools such as FMEA, risk ranking, and ICH Q9 frameworks - Knowledge of Lean Six Sigma Methodologies or equivalent is preferred - Excellent analytical, problem-solving, and project management skills with keen attention to detail - Knowledge of regulatory requirements and guidelines (e.g., FDA, ICH, EU GMP, GDP) - Proficiency in eQMS preferably with prior Veeva experience, Microsoft Office, Excel, Google Docs, etc. - Experience with commercial marketed products 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 $126,400—$152,700 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 ## About BridgeBio Pharma ## Company Overview - **One-liner**: BridgeBio Pharma develops transformative medicines for genetic conditions, using a decentralized hub-and-spoke model to accelerate drug development from early research to commercialization. - **Entity Type**: Public (Nasdaq: BBIO) - **Headquarters**: Palo Alto, California, USA (with hybrid offices in San Francisco, CA) - **Founded**: Not explicitly stated in provided sources; the company references “over the past 10 years” as of 2026, suggesting founding around 2015–2016. - **Founders**: Not publicly available from provided sources. ## Core Business - **Primary industry**: Biotechnology / Genetic disease therapeutics - **Target customers**: Patients living with genetic conditions, healthcare providers, payers, and academic research partners - **Mission**: “To develop transformative medicines for genetic conditions” and “bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations.” ## Products & Services BridgeBio’s pipeline includes both approved therapies and investigational candidates across dozens of indications. Key offerings: - **Acoramidis**: Approved for transthyretin amyloidosis (ATTR) – a first-in-class treatment with $8B+ peak year sales potential. - **Infigratinib**: Phase 3 completed for achondroplasia; published in the *New England Journal of Medicine* (2026). - **BBP-418**: Investigational for Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9). - **Encaleret**: Investigational for Autosomal Dominant Hypocalcemia Type 1 (ADH1). - **BBP-812**: Investigational for Canavan Disease. - **BridgeBio Oncology Therapeutics (BBOT)**: Subsidiary focused on RAS and PI3Kα-driven cancers. - **GondolaBio**: Subsidiary developing bioavailable small molecule inhibitors for oncology. - **Other programs**: Covering hypochondroplasia, chronic hypoparathyroidism, and more. The company has received **3 FDA approvals** and has over **70+ peer-reviewed publications**. ## Market Standing - **Valuation / Market Cap**: Not explicitly stated in provided data; as a public company, current market cap can be found on financial platforms (e.g., ~$8B based on peak sales potential, but not a direct valuation number). - **Key Metric**: **3 FDA-approved medicines**; **2000+ patients enrolled** in global clinical trials; **6 Phase 3 trials** conducted over the past 10 years. - **Notable Investors / Partners**: Not detailed in provided sources, but the company partners with leading academic institutions to advance early-stage research. - **Growth Signals**: Recent publication of Phase 3 PROPEL 3 trial results in NEJM (June 2026); expansion into oncology via BBOT and GondolaBio; 100% of pipeline is first-in-class or best-in-class; 48 unique disease indications targeted. ## Competitive Advantages - **Hub-and-spoke model**: Decentralized structure where autonomous affiliate teams (spokes) focus on specific conditions, while a central hub provides clinical, regulatory, and commercial expertise. This enables speed, scalability, and risk reduction. - **First-in-class / best-in-class focus**: 100% of pipeline aims to be first or best in class, targeting underserved genetic conditions with clear biological rationale. - **Speed and adaptability**: The model allows rapid pivoting to the most promising opportunities, reducing development timelines compared to traditional biotech. - **Strong scientific foundation**: Over 70 peer-reviewed papers and collaborations with top academic institutions. ## Strategic Focus - **Advance late-stage pipeline**: Prioritize Phase 3 programs (e.g., infigratinib for achondroplasia, acoramidis for ATTR) and seek additional FDA approvals. - **Expand into oncology**: Leverage subsidiaries BBOT and GondolaBio to address RAS/PI3Kα-driven cancers. - **Maintain urgency**: “Every minute counts” – continue to operate with speed and autonomy to bring treatments to patients faster. - **Build on commercial success**: Leverage existing approved products to fund further R&D and expand global reach. ## Why Work Here - **Award-winning culture**: Named **#1 Best Place to Work** by BioSpace (2026, small biotech category) with an **88% employee engagement score** in 2025. - **Flexible work model**: Hybrid policy with offices in San Francisco and Palo Alto, CA; “flexible working model” emphasized. - **Compensation and benefits**: Market-leading pay, comprehensive healthcare, and strong emphasis on growth and internal mobility. - **Impact-driven mission**: Work on transformative treatments for genetic conditions where patient need is urgent – “Impatient for Patients” is a core mantra. - **Values**: Put patients first, let science speak, think independently, speak up, and act with urgency. The culture is described as “high on standards, low on convention.” - **Growth opportunities**: 113 open jobs (as of mid-2026) across functions including clinical, regulatory, manufacturing, commercial, and corporate; talent community available for future roles. ## Sources 1. [bridgebio.com](https://bridgebio.com/) – Home page with pipeline overview and $8B peak sales potential 2. [bridgebio.com/about](https://bridgebio.com/about) – Company description, hub-and-spoke model, and key metrics 3. [bridgebio.com/careers](https://bridgebio.com/careers) – Careers page with awards, culture, and benefits 4. [investor.bridgebio.com](https://investor.bridgebio.com/overview/default.aspx) – Investor relations overview, latest news, and corporate presentation 5. 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