Associate Director / Director, Clinical Quality Assurance

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

QED Therapeutics, an affiliate within BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.

What You'll Do

Reporting to the Senior Director, Clinical Quality Assurance, the Associate Director / Director, Clinical Quality Assurance, supports Clinical functional areas in their management of Clinical Controlled Documents. The Associate Director / Director, Clinical Quality Assurance designs and develops Clinical Project-Specific Training Programs, is a champion for Quality System Deviation and CAPA processing and supports the Audit Program. The Director of Clinical Quality Assurance is a champion for continuous process improvement.

Responsibilities

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

• Clinical Controlled Document Management :

Own and manage Clinical Quality Assurance controlled documents in Veeva QualityDocs, including SOPs and Work Instructions

Design and manage project-specific training programs, including oversight of training matrices and compliance with SOP timelines

Serve as the primary Clinical QA lead for Quality System Deviations and CAPA processes, overseeing initiation, planning, implementation, effectiveness checks, and closure to ensure compliance and timely resolution

Review audit reports and responses for completeness and quality, ensuring alignment with QED's standards and providing actionable feedback

Support mock inspections, identify potential compliance gaps, and implement corrective actions, as needed

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

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 :

Health & Wellbeing :

Skill Development & Career Paths :

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

$170,000-$233,000 USD