Leads quality compliance, risk management, and vendor oversight programs to support late-stage development.
Manages inspection readiness, data integrity assessments, and regulatory authority interactions across GxP.
Provides senior-level quality judgment and drives risk-based decisions in a dynamic environment.
Braveheart Bio is a clinical-stage biopharmaceutical company developing therapies for hypertrophic cardiomyopathy and other cardiovascular diseases. It has a proven leadership team, strong financial foundation, and a high-value late-stage asset, offering an opportunity for mission-driven professionals.
Provide quality oversight and direction to vendors to ensure cGMP compliance for clinical manufacturing.
Lead clinical lot disposition, batch record review, and QP certification for global trials.
Oversee GMP quality systems including deviations, investigations, and audits at contract manufacturing partners.
Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for pulmonary diseases. It is a small, lean organization within the Roivant family, focusing on collaboration and innovation.
Analyze and validate technical reports, audit findings, and inspection documents for accuracy and compliance.
Evaluate corrective actions submitted by clients in response to non-conformities, verifying adequacy and timely implementation.
Monitor analysis queues and prioritize workload to ensure report delivery within defined turnaround times.
QIMA is a testing, inspection, certification, and compliance company that provides digital solutions for quality and safety data across consumer goods, food, and life sciences industries. With 6,000 employees worldwide, the company maintains a unique culture focused on customer passion, integrity, and simplifying processes.