Director/Sr. Director, Quality Assurance

📋 Description

• • As the Director/Sr. Director, Quality Assurance at BridgeBio Pharma, Inc., you will be instrumental in shaping and executing the company's Good Clinical Practice (GCP) Quality and Compliance program. This pivotal role demands a strategic thinker with exceptional judgment and business acumen to navigate the complex landscape of international regulations, corporate policies, and standard operating procedures.
• • You will serve as a key advisor to internal and external stakeholders, ensuring adherence to GCP guidelines and fostering a culture of quality and compliance across all clinical operations. Your expertise will be critical in interpreting regulatory requirements and translating them into actionable strategies that uphold the highest standards of patient safety and data integrity.
• • A significant aspect of this role involves active participation in regulatory inspections. You will be responsible for preparing for, managing, and responding to inquiries from regulatory bodies, ensuring a smooth and successful inspection process.
• • You will lead and/or actively participate in a robust internal and external GCP audit program. This includes planning, conducting, and reporting on audits of vendors, investigator sites, and internal processes to identify areas of compliance and opportunities for improvement.
• • A core responsibility is the review and approval of audit reports and the subsequent development and tracking of Corrective and Preventive Actions (CAPAs). You will ensure that identified issues are addressed effectively and that systemic improvements are implemented to prevent recurrence.
• • You will manage and/or provide significant support for regulatory inspections, including coordinating responses, managing documentation, and ensuring the timely and accurate fulfillment of any regulatory commitments.
• • You will be the conduit for critical information, communicating significant quality or patient safety risks to Executive Management and key stakeholders. Your ability to clearly articulate complex issues and recommend appropriate mitigation strategies will be vital.
• • Partnering cross-functionally is essential. You will collaborate closely with various departments to support the business in addressing compliance issues and concerns, ensuring a thorough evaluation and effective mitigation of risks.
• • You will play a key role in the continuous improvement of quality systems and processes. By identifying inefficiencies and areas for enhancement, you will contribute to the development and refinement of systems that support robust quality and compliance.
• • Staying ahead of the curve is paramount. You will be responsible for keeping abreast of changes in global GxP regulations and enforcement actions, proactively making recommendations for necessary changes to policies, procedures, and practices to maintain compliance.
• • This role offers the opportunity to work within BridgeBio's unique "moneyball for biotech" model, contributing to the development of life-changing medicines for patients with unmet needs. You will be part of a dynamic environment that values scientific innovation, collaboration, and a commitment to achieving the impossible.
• • You will be expected to demonstrate curiosity and adaptability, particularly in the ethical and thoughtful use of AI-powered tools and technologies to enhance clarity, speed, and quality in your work.
• • The position is U.S.-based and remote, with requirements for quarterly or as-needed visits to the San Francisco office, along with approximately 10-15% travel.
• • This role is ideal for a seasoned Quality Assurance professional who thrives in a fast-paced, innovative environment and is passionate about making a tangible impact on patient lives.
• • You will leverage your extensive experience to guide the organization, ensuring that all clinical activities meet the highest regulatory standards and contribute to the successful development of groundbreaking therapies.
• • Your ability to build strong relationships, influence stakeholders, and drive quality initiatives will be key to your success in this impactful leadership position.