Quality Associate III
Core
Lead high-risk, systemic, and cross-functional quality investigations to determine root causes and develop corrective actions for product safety and regulatory compliance.
Role type
Senior Quality Investigation Lead (Regulatory/Quality)
Builds
Corrective and preventive actions (CAPA), investigation reports, and quality decision frameworks
Domain
Pharmaceutical/Medical Device Manufacturing & Quality Assurance
Required skills
Root cause analysis, CAPA development, cGMP regulations, Quality risk management, Technical writing, Data analysis, Project leadership, Conflict resolution, Regulatory inspection preparation, eQMS proficiency
Preferred skills
Lean Six Sigma certification, ASQ CQE/CQA certification, Regulatory defense experience, Investigator coaching
Technologies
TrackWise, eQMS, Data analysis tools
Responsibilities
Lead complex investigations from initiation to resolution, Develop investigation strategies and risk assessments, Direct multidisciplinary teams in evidence collection and analysis, Evaluate quality and manufacturing data to identify systemic vulnerabilities, Facilitate senior-level discussions on findings and strategies, Author and present reports for internal and regulatory audits, Mentor and coach investigators
Seniority
Senior, hands-on IC