BridgeBio · 1 week ago
Director/Sr. Director, Quality Assurance
United States
Full-time
Hybrid
Director/Executive
$205K/yr - $266K/yr
15+ years expBridgeBio is a biopharmaceutical company focused on developing life-changing medicines for patients with unmet needs. The Director/Sr. Director, Quality Assurance is responsible for executing the Good Clinical Practice (GCP) Quality and Compliance program, advising stakeholders on compliance with regulations, and participating in regulatory inspections.
BiotechnologyHealth CareLife ScienceMedicalPharmaceutical
Responsibilities
Support internal and external GCP audit program
Lead and/or participate in vendor and investigator site audits
Review and/or approval of audit reports and CAPA responses
Manage and/or assist with regulatory inspections and the development and tracking of regulatory commitments
Communicate critical information regarding significant quality or patient safety risk to Executive Management and key stakeholders
Partner cross-functionally to support the business with compliance issues/concerns by ensuring appropriate evaluation and mitigation
Assist the organization with developing and continuously improving processes and systems
Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as needed
Qualification
Required
Bachelor's degree with 15+ years of relevant clinical Quality experience within a biopharmaceutical company
Current knowledge of global GxP regulations
Ability to engage in cross-functional interactions with internal and external staff
Excellent verbal and written communications skills, with a strong customer focus
Benefits
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
Financial rewards, peer-to-peer recognition, and growth opportunities
Company
BridgeBio
BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.
201-500 employees
H1B Sponsorship
BridgeBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$4.9BKey Investors
Blue OwlQatar Investment AuthorityKohlberg Kravis Roberts
2026-01-16Post Ipo Debt· $550M
2025-02-25Post Ipo Debt· $500M
2024-03-04Post Ipo Equity· $250M
Leadership Team
Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
Neil Kumar
CEO and Founder
Recent News
BioWorld Financial Watch
2026-01-17
Company data provided by crunchbase