Teams at Kashiv BioSciences LLC

Supervise QMS activities in a cGMP biologics manufacturing facility, including deviation investigations, change controls, CAPAs, document control, batch record review, audits, compliance, and continuous improvement. Lead quality data analysis, staff training, regulatory inspection support, and cross-functional resolution of manufacturing and equipment issues. The role requires onsite work in cleanroom and laboratory environments, flexible 12-hour shifts, overtime, weekends, and holidays.

Support cGMP compliance for biologics manufacturing by performing inspections, sampling, raw material release, batch and quality event documentation review, walk‑through audits, and corrective action support. Partner with cross‑functional teams to drive continuous improvement and ensure manufacturing and testing meet regulatory and company quality standards. Level of responsibility varies by MQA I–III.

Leads day-to-day operations for outsourced biologics manufacturing partners and CMO/CDMO programs. Coordinates production schedules, campaign readiness, technology transfers, validation, quality events, supply risks, partner performance, cost tracking, and cross-functional issue resolution. Supports cGMP-compliant manufacturing, inspections, investigations, and continuous improvement while providing occasional on-site campaign support. The role operates through matrix influence across Manufacturing, Quality, MSAT, Supply Chain, Regulatory, Finance, Procurement, Legal, and CMC Development.