Advancing treatments to improve outcomes and quality of life for patients with hypertrophic cardiomyopathy and related heart conditions. Backed by a16z.
About the role
The Senior Director, Quality Compliance & Risk Management reports to the Vice President of Quality and provides senior-level leadership for quality compliance, Quality risk management, vendor qualification and oversight, internal and external vendor audit programs, inspection readiness and management, data integrity, and related compliance activities.
What they're looking for
- Bachelor’s degree in life science, quality, engineering, or related discipline
- Minimum of 15 years of progressive pharmaceutical or biotechnology Quality experience
- Strong experience with evaluation of foreign clinical data
- Significant experience in Quality compliance, Quality Risk Management, inspection readiness, GxP auditing, and vendor oversight
- Demonstrated experience performing GxP gap analyses, compliance assessments, data integrity assessments, and risk-based evaluation and mitigation of identified gaps
- Demonstrated experience developing, conducting, or overseeing risk-based internal and external GxP audit programs
More about this role
Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Our lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity.
With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.
The Senior Director, Quality Compliance & Risk Management reports to the Vice President of Quality and provides senior-level leadership for quality compliance, Quality risk management, vendor qualification and oversight, internal and external vendor audit programs, inspection readiness and management, data integrity, and related...
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