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 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.

Affiliate Overview

BridgeBio Gene Therapy, an affiliate within of BridgeBio Pharma, is focused on discovering and developing drugs for patients with grievous rare genetic diseases by finding the right starting points to target diseases at their source and by building products with a world-class R&D personnel team. Using a combination of a systematic assessment of the genetic disease landscape and informed diligence on the latest research, we find indications with clear mechanisms of pathogenesis that are ripe for translation into disease-modifying drugs.

What You'll Do

Reporting to the Vice President, Clinical Quality Assurance, the Sr. Director, Clinical Quality Assurance, will define and support the quality oversight and management of GCP activities internally at BBGT (and other affiliates as directed) and externally with BBGT vendors, consultants, and service providers, including, but not limited to, quality systems management, document review, and approval.

Responsibilities

In partnership with Clinical QA management, drive strategy and execution of the following:

• Lead the development, management and maintenance of Clinical aspects of BBGT’s Quality Management System procedures and related processes for continuous improvement.
• Lead inspection readiness activities and provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable.
• Manage direct reports and consultants, as needed, in the pursuit of Clinical Quality Assurance objectives.
• Partner with clinical study teams to coordinate appropriate and timely documentation of quality event management, including corrective action and preventive action (CAPA) plans, as necessary.
• Provide Clinical Quality Assurance (GCP) leadership and Subject Matter Expertise (SME) to clinical study teams.
• Author and maintain QA Standard Operating Procedures (SOPs). Support management of other functional area SOPs.
• In collaboration with functional area leads, support training oversight.
• Lead process improvement projects as needed.
• Provide Clinical Quality Assurance SME to reviews of clinical protocols, amendments, Clinical Study Reports, and other clinical trial-related documents.
• Plan, conduct, and/or assist in internal and external service provider audits. Review audit reports, and any corresponding corrective and preventative actions for adequacy.
• Other duties as assigned or required.

Where You’ll Work

This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Demonstrated expertise in guiding development of the Quality Management System.
• Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and vendors.
• Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges.
• Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events.
• Bachelor's degree in a scientific discipline or equivalent experience.
• Minimum of 8 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred.
• Expertise with applicable GCP guidelines.
• Experience with Veeva platform highly preferred.

Rewarding Those Who Make The Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

Financial Benefits

• Market leading compensation.
• 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.

Health & Wellbeing

• 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.

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, Spring Health & BetterUp Coaching.
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.

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

$225,000 - $260,000 USD