Quality Project Lead
Core
Lead quality systems and compliance activities for oral solid drug manufacturing, ensuring regulatory adherence and driving continuous improvement.
Role type
Senior Quality Project Lead (Pharmaceutical Manufacturing)
Builds
Oral solid dosage forms, controlled release formulations, and abuse-deterrent dosage forms
Domain
Pharmaceutical manufacturing / Life Sciences
Required skills
Root cause analysis, CAPA management, deviation management, change control, audit execution, GMP/GxP compliance, risk assessment, statistical analysis, technical writing
Preferred skills
Project management, client-facing experience, pharmaceutical/medical device/biotech industry experience
Technologies
TrackWise, document control systems, Microsoft Office
Responsibilities
Investigate quality issues using root cause analysis; Manage and support CAPA, deviation, and change control processes; Conduct and host internal and external audits and support regulatory inspections; Author and maintain SOPs, investigation reports, and other quality documentation; Analyze quality data, trends, and metrics to identify opportunities for improvement; Apply risk assessment methodologies and continuous improvement tools
Seniority
Senior, hands-on IC
