Associate Director, Clinical Quality and Continuous ImprovementAlnylam Pharmaceuticals
Remote — United States
NA
Minimum of 8 years of experience in GCP Quality Assurance, Clinical Quality, or GCP-focused roles within the pharmaceutical, biotech, or CRO environment.Experience leading enterprise improvement efforts that include application of DMAIC/Lean methods and Change Management techniques preferred.Strong experience in GCP regulations, inspection readiness, and audit/quality systemsDemonstrated experience in process improvement, quality systems, or operational excellence initiatives.Experience with root cause analysis, CAPA management, and issue management frameworks.Proven ability to work across multiple studies/programs and influence cross-functional stakeholders.Prior experience with quality metrics, data analytics, and compliance metrics to drive decision-making.Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements.Experience with regulatory inspections and audits (FDA, EMA, or other health authorities).
Deadline:28 Oct 2026


