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. Location: This is a U.S.-based remote role with quarterly or as-needed visits to the San Francisco Office and 10-15% travel.

Responsibilities

• Support internal and external GCP audit program
• Lead and/or participate in vendor and investigator site audits
• Review and/or approve 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

Education

• Bachelor’s degree (in a relevant field)

Additional Requirements

• U.S.-based remote role with quarterly, or as-needed visits to the San Francisco Office plus 10-15% travel