GCP Quality Associate Director
$160,600–$240,800 year
Hybrid · Boston, Massachusetts, United States
Job Summary
Associate Director of GCP Compliance responsible for quality assurance and management of GCP quality events, investigations, CAPAs, Root Cause Analysis, and KPI/metrics reporting. Lead cross-functional activities with Quality Leads, study teams, and stakeholders; perform triage of event criticality, escalate major findings, and support inspection readiness. Utilize data-driven approaches to monitor investigations, create and maintain deviation records in the Quality Management System, generate dashboards/reports, and drive continuous improvement. May supervise direct reports, assist in onboarding/training, and participate in quality initiatives including audits and risk assessments. Hybrid work arrangement with optional remote up to two days per week or on-site five days per week.
Required Qualifications
- Bachelor’s Degree
- 10 years of relevant work experience
- GCP quality management experience
- Experience leading event investigations, Root Cause Analysis and CAPA
- Strong communication, problem solving and critical thinking skills
- Knowledge of quality analytics and data-driven decision making
- Experience with Health Authority inspections and audits
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