Teams at Orca Biotech

Leads the pharmacovigilance function, including safety data review, risk management, regulatory documentation, inspection readiness, signal detection, labeling, and safety governance. Provides cross-functional product safety leadership, oversees regulatory filings and compliance with US and EU requirements, manages resources and budgets, and mentors the pharmacovigilance team in a small biotechnology environment.

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.

Support the CEO and President by coordinating executive priorities, preparing board and executive materials, driving cross-functional strategic initiatives, improving operating rhythms, and tracking progress on company priorities. Act as a central coordinator for communication, decision-support, and follow-through across leadership teams to scale organizational effectiveness during the companys transition to commercial-stage.