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 systems
Demonstrated 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).

Associate Director, Clinical Quality and Continuous Improvement

Summary