Director/Sr. Director, 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.

What You'll Do

The Director/Sr. Director, Quality Assurance is responsible for executing the Good Clinical Practice (GCP) Quality and Compliance program at BridgeBio.  It requires strong judgement skills and business acumen in order to advise internal and external key stakeholders on interpretation and compliance with international regulations/guidelines; corporate policies; and standard operating procedures (SOPs).  This individual will also be an active participant in regulatory inspections.

Responsibilities

• Support internal and external GCP audit program
• Lead and/or participate in vendor and investigator site audits
• Review and/or approval of audit reports and CAPA responses
• Manage and/or assist with regulatory inspections and the development and tracking of regulatory commitments
• Communicate critical information regarding significant quality or patient safety risk to Executive Management and key stakeholders
• Partner cross-functionally to support the business with compliance issues/concerns by ensuring appropriate evaluation and mitigation
• Assist the organization with developing and continuously improving processes and systems
• Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices 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 plus 10-15% travel

Who You Are

• Bachelor’s degree with 15+ years of relevant clinical Quality experience within a biopharmaceutical company
• Current knowledge of global GxP regulations
• Ability to engage in cross-functional interactions with internal and external staff
• Excellent verbal and written communications skills, with a strong customer focus
• This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office plus 10-15% travel

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

Health & Wellbeing:

• 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

Skill Development & Career Paths:

• 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