Associate Director, Quality Systems Monitoring & Excellence

10+ years of progressive Quality Assurance/Quality Systems experience in the biotechnology, pharmaceutical, or medical device industry, including people leadership.

Strong knowledge of global GxP regulations, including FDA, EMA, ICH, and applicable international quality standards.

Demonstrated experience leading regulatory inspections, internal audits, Quality Management Reviews (QMRs), and Quality Systems governance.

Experience with electronic Quality Management Systems (eQMS), such as Veeva Vault or equivalent.

Experience supporting late-stage clinical development and commercial products.

Knowledge of AI-enabled quality solutions, digital transformation, data analytics, and executive dashboard development.

Lead the Global Quality Systems Monitoring & Excellence program to ensure effective governance, compliance, and continuous improvement across the Quality Management System (QMS).

Drive global audit and regulatory inspection readiness by leading inspection planning, mock inspections, execution support, response coordination, and post-inspection remediation.

Develop and monitor Quality KPIs/KQIs, analyze trends, identify systemic risks, and provide executive reporting through Quality Management Reviews (QMRs).

Perform Quality System health assessments and effectiveness reviews to identify compliance gaps and drive sustainable improvements.

Oversee CAPA governance related to internal audits & inspections, root cause analysis, effectiveness verification, and closure of audit and inspection commitments.

Lead the management of critical quality issues and escalations, facilitate timely cross-functional investigations and remediation plans, and ensure effective resolution of compliance risks and regulatory commitments.