Director/Sr. Director, Quality Assurance

Who you are

You have extensive experience in quality assurance, particularly in the biotech or pharmaceutical industry, with a strong focus on Good Clinical Practice (GCP). Your background includes managing compliance programs and conducting audits, ensuring adherence to international regulations and corporate policies. You possess excellent judgment skills and business acumen, allowing you to effectively advise both internal and external stakeholders on compliance matters. Your ability to navigate complex regulatory environments makes you a valuable asset to any team.

You are proactive and detail-oriented, with a track record of successfully leading audit programs and managing corrective action plans (CAPAs). Your experience includes reviewing and approving audit reports, and you are comfortable participating in regulatory inspections. You thrive in environments that require collaboration and communication, and you are adept at building relationships with key stakeholders.

You are passionate about improving processes and ensuring the highest standards of quality in clinical research. Your commitment to excellence drives you to continuously seek ways to enhance compliance and quality assurance practices within your organization. You understand the importance of fostering a culture of quality and compliance, and you are dedicated to mentoring and guiding your team in achieving these goals.

Desirable

Experience with regulatory inspections and a deep understanding of GCP guidelines are highly desirable. Familiarity with risk management and quality management systems will set you apart as a candidate. You may also have experience in training and developing teams in quality assurance practices, contributing to a culture of continuous improvement.

What you'll do

As the Senior Director of Quality Assurance at BridgeBio, you will be responsible for executing the GCP Quality and Compliance program. This includes leading internal and external GCP audit programs, managing vendor and investigator site audits, and ensuring compliance with international regulations and corporate policies. You will review and approve audit reports and CAPA responses, providing guidance and support to your team throughout the process.

You will actively participate in regulatory inspections, representing the organization and ensuring that all compliance matters are addressed effectively. Your role will involve collaborating with various departments to ensure that quality assurance practices are integrated into all aspects of clinical research. You will work closely with project teams to identify potential compliance risks and develop strategies to mitigate them.

In addition to your auditing responsibilities, you will play a key role in developing and implementing training programs for staff on GCP and compliance matters. Your leadership will help foster a culture of quality and compliance within the organization, ensuring that all team members understand the importance of adhering to regulatory standards.

You will also be responsible for monitoring industry trends and changes in regulations, ensuring that the organization remains compliant with evolving standards. Your insights will help shape the organization's quality assurance strategy and drive continuous improvement initiatives.

What we offer

BridgeBio offers a competitive salary range of $200,000 to $262,736 USD, reflecting your experience and expertise in the field. We provide a supportive and collaborative work environment where innovation is encouraged, and your contributions can make a significant impact on the lives of patients with unmet needs. Join us in our mission to redefine the future of biopharma and make a difference in the world of rare diseases.