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
  • Develop, review, and approve documents to ensure alignment with regulatory standards and industry best practices across Clinical functional areas
  • Oversee document workflows and approval status in Veeva, ensuring timely progression and resolution of delays
  • Collaborate on centralized Clinical document strategy with QED and cross-functional BBIO teams, fostering continuous improvement
• Clinical Project-Specific Training (PST):
  • Design and manage project-specific training programs, including oversight of training matrices and compliance with SOP timelines
  • Administer training activities in Veeva, partnering with existing administrators and Clinical Operations to manage ownership transitions
  • Lead QA support for PST escalations, addressing late submissions, versioning issues, and audit readiness
  • Drive process improvements and alignment, contributing to SOP updates and presenting training metrics in Quality Management Reviews
• Deviation/CAPA Champion:
  • 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
  • Drive deviation investigations and risk assessments, collaborating with Clinical teams to perform root cause analysis and ensure alignment with SOPs and regulatory expectations
• Audit Report/Response:
  • Review audit reports and responses for completeness and quality, ensuring alignment with QED’s standards and providing actionable feedback
  • Ensure timely and compliant documentation of audit reports and responses in accordance with SOPs and regulatory expectations
• Regulatory Authority Inspection Readiness:
  • Support mock inspections, identify potential compliance gaps, and implement corrective actions, as needed
• 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

• Bachelor’s degree in a scientific discipline or equivalent experience
• Minimum 6 years in a GCP-regulated environment; Clinical Quality Assurance or related role preferred
• Expertise