Senior Manager, Clinical Quality Assurance

About Us

We are a global team of like-minded Med-Tech professionals focused on patient-centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enable chronic MCS therapy to be accessible to more patients across the globe.

Responsibilities

• Develop, implement, maintain, and continuously improve BrioHealth's Clinical Quality Management System (CQMS).
• Ensure clinical quality processes comply with applicable FDA regulations, Good Clinical Practice (ICH E6(R3)), ISO 14155, and company procedures.
• Establish and maintain risk-based quality management practices, including quality planning, risk assessments, critical process monitoring, and quality metrics.
• Identify emerging compliance risks, conduct trend analysis, and recommend timely mitigation strategies.
• Provide independent quality oversight of clinical studies, including investigator sites, CRO and vendor performance, monitoring activities, protocol compliance, and subject protection.
• Review monitoring reports, quality findings, protocol deviations, and quality metrics to identify systemic issues and recommend corrective actions.
• Partner with Clinical, Regulatory Affairs, Quality Assurance, Medical Affairs, investigators, CROs, and vendors to strengthen clinical quality and compliance.
• Plan and coordinate internal clinical audits, investigator site audits, CRO audits, and vendor audits.
• Maintain inspection readiness across BrioHealth clinical studies and prepare teams for FDA Bioresearch Monitoring (BIMO) inspections and other regulatory audits.
• Serve as the clinical quality representative during audits and inspections and support responses to observations and findings.
• Manage clinical CAPAs arising from audits, monitoring observations, protocol deviations, regulatory inspections, and other quality events.
• Facilitate root cause investigations, assess CAPA effectiveness, and monitor recurrence and closure trends.
• Develop clinical quality dashboards and track protocol deviations, monitoring findings, audit observations, training compliance, and other quality indicators.
• Prepare concise quality reports, trend analyses, and recommendations for management.
• Develop and deliver training on GCP, clinical quality, inspection readiness, and clinical quality system requirements.
• Promote a culture of quality, compliance, and continuous improvement across BrioHealth's clinical programs.

Requirements

• Bachelor's degree in nursing, life sciences, biomedical engineering, health sciences, pharmacy, or a related discipline; an advanced degree or clinical credential is preferred.
• 8+ years of experience in Clinical Quality Assurance, Clinical Quality, Clinical Operations, or Clinical Research within the medical device industry.
• Experience supporting FDA-regulated IDE clinical trials and applying Good Clinical Practice (GCP) principles throughout the clinical study lifecycle.
• Demonstrated experience conducting GCP audits, managing CAPAs, performing root cause investigations, and implementing risk-based quality management practices.
• Strong working knowledge of FDA regulations (21 CFR Parts 50, 56, and 812), Good Clinical Practice (ICH E6(R3)), ISO 14155, and Clinical Quality Management Systems (CQMS).
• Experience supporting FDA Bioresearch Monitoring (BIMO) inspections, regulatory inspections, or inspection readiness activities.
• Strong auditing, analytical, investigation, project management, and written and verbal communication skills.