Hiring: Quality Assurance Director / Sr. Director (GVP/PV) Company: BridgeBio Location: San Francisco, CA Job Posted Time: 2026-09-16 11:47:39 Employment Type: Full-time / Hybrid Target Skills & Keywords : Quality Assurance, Regulatory Compliance About the job Experience: •15+ years of GVP quality and compliance experience within a biopharmaceutical company, or contract research organization Required Skills: •Provide strategic and operational guidance to the organization, including, drug safety/pharmacovigilance, medical affairs, regulatory, commercial, clinical operations and outsourcing functions, to align with company procedures, regulatory requirements and best practice •Actively facilitate and support internal and external GVP audit program •Oversee audit schedule and the execution of the audit program •Lead or co-lead auditor on PV audits as needed •Review and/or approval of audit reports and corrective and preventive action (CAPA) responses •Maintain and contribute of audit and quality data for the Pharmacovigilance System Master File (PSMF) •Core GVP regulatory inspection team member •Lead or participate in inspection readiness activities Qualifications: •Bachelor’s degree with 10-15+ years of GVP quality and compliance experience within a biopharmaceutical company, or contract research organization •Current knowledge of global GVP regulations and guidelines – US Code of Federal Regulations, EMA, MHRA, and ICH Guidelines •Demonstrated capacity to engage in cross-functional interactions with internal and external staff •Has a comprehensive understanding of current approaches in industry and the ability to incorporate them into Eidos and BridgeBio affiliate programs •Applies strong analytical and business communication skills Compensation: •$213,700 - $280,000 / year •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!