Quality Assurance Director / Sr. Director (GVP/PV)
Company: BridgeBio
Location: San Francisco
Posted on: April 1, 2026
|
|
|
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 excitementread 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. Company
Overview 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 . What You’ll Do 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.
Responsibilities 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 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 Host or support of regulatory
inspections Perform quality review of inspection requests Oversee
the development and tracking of regulatory responses/commitments
Review of Quality Agreements and PV/Safety Data Exchange Agreements
(PVA/SDEA) to assess quality standards and regulatory compliance
requirements Participate in the investigation and assessment of
PV/GxP-related quality events and provide input on proposed CAPAs
Develop, generate and present PV quality/compliance metrics for
trending and process improvement Provide quality oversight on
PV-related computer system validation projects and maintenance of
systems Collaborate with Eidos and BridgeBio affiliate companies to
develop and continuously improve processes and systems, including
policies, SOPs and training plans Partner cross-functionally to
support the business with compliance or quality issues/concerns by
ensuring appropriate evaluation, mitigation and escalation to
Executive Management Keep abreast of changes in regulations and
enforcement actions and make recommendations for changes to
policies and practices as needed Where You’ll Work This is a hybrid
role and will require in-office collaboration in our San Francisco
Office. Who You Are 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 Ability 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 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 $245,000 - $280,000
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 USA 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
Keywords: BridgeBio, Rohnert Park , Quality Assurance Director / Sr. Director (GVP/PV), Science, Research & Development , San Francisco, California