BridgeBio

QA Engineer

• Lead and manage global Quality Agreements/QTAs by developing, reviewing, executing, and maintaining agreements, ensuring compliance with the scope of services, regulatory requirements, internal standards, and all terms and conditions
• Collaborate with internal cross-functional teams and external stakeholders (e.g., contract service providers) to bring Quality Agreements to an approvable state
• Track Quality Agreement renewal and revision cycles
• Support regulatory authority inspection readiness activities at CSP and internally
• Participate in the global supply chain vendor qualification process to ensure compliance with regulatory and internal standards
• Participate in the planning of internal audits
• Ensure audit findings are followed up on, corrective actions are completed, implemented, and verified to ensure compliance
• Identify and assess risks to compliance, develop mitigation strategies, and ensure effective implementation
• Maintain master vendor list with up-to-date Health Authority certification/licenses
• Maintain risk registers and communicate risk trends to Quality leadership
• Develop, track, analyze, and present Quality Compliance metrics, including audit data, CAPA performance, Quality Agreement KPIs, risk assessments, and vendor performance indicators
• Prepare quality dashboards and monthly/quarterly reports for management review
• Support SOP development and revision related to Quality Agreements, auditing, risk management, and metrics
• Other duties as assigned

Manager, QA Compliance

Medical Director

• Support development and execution of the United States Medical Affairs strategy for encaleret in ADH1 and chronic hypoparathyroidism, including launch readiness and lifecycle planning with scientific rigor and patient focused decision making
• Support integrated evidence generation planning and execution, including real world evidence, Phase 4 studies, registries, investigator-initiated research support, and data integration activities
• Support omnichannel HCP engagement by enabling field and digital scientific exchange, gathering insights, and translating themes into Medical Affairs programs and tactics
• Support strategic relationships with key opinion leaders, investigators, and external stakeholders across endocrinology, nephrology, and related specialties, and co-lead advisory boards and expert panels
• Partner with Clinical Development to support ongoing and planned clinical trials and contribute to data disclosure and publication planning with Scientific Communications
• Support peer to peer scientific exchange and external education programs, including congress and clinical meeting preparation and scientific materials development
• Partner with Congress Operations and Scientific Communications to define congress strategy, align scientific narratives and data priorities, and deliver coordinated pre congress, onsite, and post congress medical plans
• Ability to travel up to ~40% for scientific meetings, advisory boards, and internal engagements

Associate Medical Director, Medical Affairs

Procurement

• The Sr. Manager of Clinical Outsourcing leads vendor outsourcing, negotiation, contracting, and vendor relationship management for assigned vendor categories and functions across specified BridgeBio affiliates within BridgeBio’s clinical development portfolio.
• This position will work closely with internal and external stakeholders to ensure the successful, cost-effective, and timely alignment on decision-making, approvals, and execution of contracts across BridgeBio programs and affiliates.
• S/he will be responsible for leading the request for information/proposal (RFI/RFP) processes and vendor selection for specific vendors and programs; analyzing bids, negotiating clinical development service provider contract business terms, reviewing and negotiating change orders and budgets; managing financial and contract approvals while consistently fostering an environment of collaboration and transparency between internal stakeholders and external business partners.
• This role will be responsible for but is not limited to managing ancillary clinical vendors including labs, specialty vendors, IRT, clinical technologies, and other supporting clinical trial vendors and will work across multiple affiliates.

Senior Manager, Clinical Outsourcing

Director

• Develop and execute the Central Europe Region market access priorities, including pricing, reimbursement, and launch sequence, aligned with global and regional frameworks
• Lead HTA and payer engagement strategy – with a strong focus on AMNOG, ensuring early, proactive dialogue with national and regional decision-makers to anticipate requirements and reduce access risk
• Own country value dossier strategy and adaptation: incl. comparator selection, evidence gaps, risk mitigation. Thereby ensuring high-quality, locally relevant submissions delivered on time and supporting favourable reimbursement outcomes
• Define and implement pricing strategy, including list price, net price corridors, and contracting principles, while protecting long-term value and portfolio optionality
• Coordinate cross-functionally with Medical Affairs, Commercial, Regulatory, and Finance to align evidence generation, access strategy, and launch readiness, as well as post-launch accounting of rebates and related accruals
• Develop, implement and maintain compliant incentive structures for buying groups in Germany
• Assess potential and advocate for cost coverage and tailored solutions for individual SHIs in Germany

Senior Director, Market Access, Europe Central Region

Compliance

• Provide strategic and operational leadership for global CMC regulatory activities across development and (as applicable) commercial products
• Partner closely with CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs leadership to define regulatory CMC strategy, ensure high-quality submissions, and enable product development, licensure, and lifecycle management.
• Lead preparation, review, and approval of CMC sections for regulatory submissions (Module 3, quality overall summaries, responses to information requests)
• Develop and manage CMC-related briefing packages, meeting requests, and responses for global health authority interactions (FDA, EMA, MHRA, PMDA, etc.)
• Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.

Executive Director, Regulatory CMC

Recruitment

• Partnering with leaders
• Shaping hiring strategies
• Contributing to meaningful growth

Manager, QA Compliance

Associate Medical Director, Medical Affairs

Senior Manager, Clinical Outsourcing

Senior Director, Market Access, Europe Central Region

Executive Director, Regulatory CMC

Talent Acquisition