Director/Sr. Director, Quality Assurance

Role Summary

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

Qualifications

• Bachelor‚Äôs 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

Location

U.S.-based remote role with quarterly visits to San Francisco Office and 10-15% travel.