Quality Assurance Director / Sr. Director (GVP/PV)

Current knowledge of global GVP regulations and guidelines – US Code of Federal Regulations, EMA, MHRA, and ICH Guidelines

Has a comprehensive understanding of current approaches in industry and the ability to incorporate them into Eidos and BridgeBio affiliate programs

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.

Market-leading compensation

Employee Stock Purchase Program (ESPP)

Subsidized lunch and parking

The Director / Senior Director, Quality Assurance is responsible for managing and overseeing the Good Pharmacovigilance Practices (GVP) quality and compliance program at Eidos Therapeutics and other assigned BridgeBio affiliate companies.

It requires strong judgement skills and business acumen in order to advise internal and external key stakeholders on interpretation and compliance with FDA, EMA, MHRA and international pharmacovigilance (PV) regulations/guidelines; corporate policies; and standard operating procedures (SOPs).

This individual will be a lead point of contact in the preparation and management of GVP regulatory inspection activities.

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

Support the internal and external GVP audit program

Oversee audit schedule and the execution of the audit program

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at

bridgebio.com

.