Develop and report key quality metrics across all clinical programs and trials.
Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations.
Drive inspection readiness at local and global levels.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.
Lead Braveheart’s global PV strategy and partner closely with Clinical, Regulatory, and other development functions.
Lead all PV contributions to Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions worldwide, with responsibility for developing high-quality safety sections.
Shape the future PV function— its people, structure, and operating model— as Braveheart transitions from clinical development to post-market commercialization.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease.
Lead the development and execution of Care Access’s quality program across clinical, operational, and technology domains.
Build and maintain a risk-based, fit-for-purpose Quality Management System (QMS) that supports Care Access’s mission.
Collaborate with Operational Compliance, Product, Privacy, IT, and other functional partners to embed quality by design across systems and workflows.
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, they bring world-class research and health services directly to communities that often face barriers to care.
Owns the CAPA system and leads as the Subject Matter Expert (SME).
Leads cross-functional teams in facilitating CAPA Boards and Root Cause Analysis teams.
Monitors KPIs and drives systemic improvements to ensure products meet the highest standards.
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology.