Director/Sr. Director, Quality Assurance

Role Summary

Director/Sr. Director, Quality Assurance responsible for executing the Good Clinical Practice (GCP) Quality and Compliance program at BridgeBio. Advises stakeholders on interpretation and compliance with international regulations/guidelines, corporate policies, and SOPs. 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 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‚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 is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office plus 10-15% travel

Skills

• GCP quality management
• Regulatory inspections and CAPA management
• Cross-functional collaboration
• Regulatory compliance and risk assessment

Education

• Bachelor‚Äôs degree (as listed in Qualifications)

Additional Requirements

• Travel: 10-15% as needed