Software Gigs

The Quality Assurance Specialist II independently owns and operates defined Quality Management System processes, serving as a subject matter expert for batch release, NCMR/deviation/CAPA management, and asset control. The role requires judicious decision-making on routine and moderately complex quality and compliance matters, including investigating quality events, driving corrective actions, and supporting regulatory submissions and FDA inspections. The specialist works collaboratively with a QA Associate and Sr. Quality Systems Engineer, leading process improvements and providing escalation support with minimal oversight.

Lead enterprise-level Clinical Data Management function across a biopharmaceutical company's clinical development portfolio. Establish CDM strategy, governance framework, operating model, and capability roadmap while ensuring accurate, complete, timely, inspection-ready clinical trial data. Drive data quality, risk management, database readiness, and cross-functional collaboration with biostatistics, statistical programming, and CRO/vendor partners. Oversee the clinical data lifecycle from protocol and CRF design through SDTM-ready analysis data.