Associate Director, Clinical Quality Assurance

BridgeBio Pharma•San Francisco, CA

12d•Hybrid

About The Position

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 T herapeutics, 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, Clinical Quality Assurance, supports Clinical functional areas in their management of Clinical Controlled Documents. The Associate 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 Associate Director of Clinical Quality Assurance is a champion for continuous process improvement.

Requirements

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 in applicable GCP guidelines and regulatory expectations
Strong collaboration and relationship-building skills across internal teams and external vendors
Skilled in negotiation and solution-based approaches to complex challenges
Excellent verbal and written communication; able to manage multiple priorities under pressure

Nice To Haves

2+ years of experience with Veeva administration highly preferred

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
C linical 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

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
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
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