[Hiring] Director/Sr. Director, Quality Assurance @BridgeBio Pharma

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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. • 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 Qualifications • 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 Requirements • This is a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office plus 10-15% travel 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 Salary $230,390.33 — $262,736 USD Apply tot his job