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

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

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 excitement... read on.

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia 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 and 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 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, with two approved drugs. Our focus is scientific excellence and rapid execution to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites elsewhere. We also have international offices in Montreal and Zurich, and are expanding across Europe. To learn more, visit 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 BridgeBio affiliates. The role requires strong judgement and business acumen to advise internal and external stakeholders on interpretation and compliance with FDA, EMA, MHRA and international PV regulations/guidelines; corporate policies; and SOPs. This person will be a lead point of contact in 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 CAPA responses.
• Maintain and contribute to 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 regulatory inspections.
• Perform quality review of inspection requests.
• Oversee the development and tracking of regulatory responses/commitments.
• Review of Quality Agreements and PV/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 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 CFR, EMA, MHRA, and ICH Guidelines.
• Ability to engage in cross-functional interactions with internal and external staff.
• Comprehensive understanding of current industry approaches and ability to incorporate them into Eidos and BridgeBio affiliate programs.
• Strong analytical and business communication skills.

Compensation & Benefits

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, annual bonus, equity, and comprehensive health benefits. Salary range for California is $245,000 - $280,000 USD. Final offer dependent on factors including experience, education, location, and performance during the interview.

• Market-leading compensation
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre-tax commuter benefits
• Referral bonus
• Subsidized lunch and parking on in-office days
• 100% employer-paid medical, dental, and vision premiums for you and your dependents
• Health Savings Account (HSA) with employer contributions, plus FSA
• Fertility & family-forming benefits
• Expanded mental health support
• Hybrid work model with flexibility
• Flexible, take-what-you-need paid time off and company-paid holidays
• Comprehensive paid medical and parental leave

Skill Development & Career Paths:

• People are part of our growth and success from discovery to FDA pipelines; opportunities for skill development and internal mobility
• Career pathing through regular feedback, continuous education and professional development via LinkedIn Learning, LifeLabs, & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

#J-18808-Ljbffr