Senior Specialist, Quality Assurance
Core
Ensuring reliable availability, quality, and regulatory compliance of clinical supplies for clinical development programs.
Role type
Senior Specialist, Clinical Supplies Quality
Builds
Clinical supply chain operations and integration for R&D programs
Domain
Pharmaceutical industry, Clinical Development, Medical Devices
Required skills
cGMP compliance, Deviation management, CAPA management, Quality Risk Management, Process improvements, Six Sigma, Batch disposition, Stakeholder management
Preferred skills
Lean Six Sigma, Project Management, ERP/MES systems, Medical Device/Combination Products expertise
Technologies
SAP, Trackwise, Excel, PowerPoint, Word
Responsibilities
Evaluate and disposition clinical supply materials for regulatory compliance; Coordinate investigation of deviations and significant quality events; Identify trends and proactively resolve quality issues; Develop and execute quality strategies and improvement initiatives.
Seniority
Senior, hands-on IC