Orca Biotech Benefits Overview

Manage cross-functional life sciences projects from initiation through implementation, focusing on CMC, technical operations, manufacturing, quality, supply chain, and clinical initiatives. Own project plans, schedules, risks, dependencies, deliverables, meetings, dashboards, RAID logs, and executive communications. Coordinate regulated implementation activities involving GMP, validation, change controls, and operational readiness while supporting PMO governance and portfolio management.

Supports quality assurance systems in a regulated cell therapy manufacturing environment. Responsibilities include managing deviations, change controls, CAPAs, and document control; reviewing batch records and release data; supporting investigations, audits, cGMP compliance, staff training, and continuous improvement initiatives. Collaborates with manufacturing, quality control, and R&D teams while maintaining data integrity and accurate quality documentation.

Support execution and documentation of process improvements, change controls, CAPA, and SOP development in a GMP-regulated cell therapy manufacturing facility. Coordinate data collection, assist root cause investigations, track project milestones, and facilitate cross-functional meetings and training to ensure compliant implementation of production changes.