Executive Director, Quality Operations

Summary

Join BridgeBio as an Executive Director, Quality Operations, and play a vital role in developing and improving their GXP Quality Management System (QMS). Reporting to the SVP of Quality Assurance, you will lead the implementation and improvement of electronic systems, support clinical and commercial manufacturing needs, and spearhead quality initiatives. This U.S.-based remote role requires quarterly visits to the San Francisco office. Responsibilities include managing GxP electronic systems, overseeing continuous improvement projects, and developing and improving various QMS processes. You will guide process owners, establish policies and standards, track quality metrics, and ensure compliance with regulatory standards. The position offers a competitive salary and a comprehensive benefits package.

Requirements

• BA or BS degree in a scientific discipline or comparable experience
• 15+ years of experience in a pharmaceutical or biotech environment in Quality Assurance, Quality Control, QMS or a GxP operational role
• Minimum of 5 years of managing Quality Management Systems
• Minimum of 5 years of experience with Phase 3 and/or commercial bio-pharm manufacturing
• 3+ years of experience in an outsourced manufacturing environment
• Strong technical skillset and experience in implementing and validating cloud-based (hosted) computer systems
• Position requires 10-20% travel
• Thorough knowledge of applicable regulations such as 21CFR Part 11, 210, and 211; ICH Q1–Q11 and E1-E8

Responsibilities

• Select, implement, manage, and oversee GxP electronic systems
• Manage a portfolio of interrelated continuous improvement projects and initiatives
• Develop, implement, manage, continuously improve, and oversee: Document Management, Training Management, Change Control, Management Review (MR), Annual Product Quality Review (APQR), Deviation/CAPA/ Risk Management, and GxP Computer System Assurance
• Guide and support GxP process owners with implementation and improvement /optimization of key functional area processes
• Establish and improve policies, standards and standard operating procedures for efficient and compliant management of GxP QMS processes
• Establish, track and report quality metrics for QMS processes and present improvement opportunities at Management Review meetings
• Implement phase appropriate, risk-based, fit-for-purpose approaches to QMS processes
• Support the BridgeBio Quality management team in ensuring that QMS processes comply with applicable regulatory standards, regulations and guidelines
• Maintain awareness of new regulations, technologies, trends and apply as relevant
• Manage resources to achieve company, department and functional area goals and objectives
• Contribute to the development and maintenance of a positive team-focused company culture
• Day to day support, development, and management of direct reports

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
• $260,000 — $300,000 USD