Executive Director, Quality Operations

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.

What You'll Do

Reporting to the Senior Vice President of Quality Assurance, the Executive Director, Quality Operations is a vital member of the BridgeBio Quality leadership team, responsible for driving and delivering the activities necessary to develop, implement, and continuously improve BridgeBio’s GXP Quality Management System (QMS). The Executive Director will be responsible for the implementation and improvement of electronic systems in support of QMS processes, plan for and support future clinical and commercial manufacturing and supply chain needs, and support or lead quality initiatives to support the growth of the organization. 

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

Where You'll Work

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

Who You Are

• 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 

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