• Provides strategic and operational support within GMP Quality and Quality Systems • Leads training initiatives • Provides vendors management support • Drives process improvement • Partners cross-functionally to support successful Quality operations • Contributes to the continuous evolution of the CSV program, training management program, and strategy for improvement of cross-functional Quality Compliance • Supports day-to-day operational quality oversight for internal batch record review, batch disposition and manufacturing operations across the end-to-end manufacturing processes for the manufacture of clinical and commercial intermediates and drug product batches • Monitors operational activities and assesses continuous improvement within the QA operations • Serves as QA partner on change controls, CAPAs, deviations, OOS, and non-conformances • Facilitates root cause / A3 problem solving and partners with business partners on deviations/CAPAs (close on time, prove effectiveness) • Drafts, revises, reviews, and/or approves controlled documents including Standard Operating Procedures • Represents QA on cross-functional project teams and with external partners • Identifies and anticipates trends in quality issues; collaborates with leadership team to implement quality initiatives • Responsible for managing CSV oversite including planning and scheduling validation activities with external vendors • Ensures business partners assess and approve change controls for commercial processes for assessment of lot disposition processes • Identifies areas of improvement in training system performance, training process and overall training procedures • Manages training KPIs • Ensures business partners implement adequate training modules and learning activities • Contributes to the development, maintenance, and continuous improvement of SOPs, work instructions, and templates