Jobs at Orca Biotech

Leads QA and QC operations for a biotechnology manufacturing site, ensuring cGMP compliance, inspection readiness, batch review, product release, deviation investigations, change control, CAPA, complaints, QC testing, laboratory investigations, and assay transfer or validation. Partners with Manufacturing, MSAT, Supply Chain, Regulatory, and R&D teams to support clinical manufacturing, technology transfers, production timelines, and continuous improvement. Oversees quality teams, metrics, dashboards, and site quality systems.

Monitor clinical studies at investigative sites or remotely, ensuring protocol, ICH-GCP, SOP, and regulatory compliance. Responsibilities include site monitoring visits, source data verification, medical record and adverse event review, site staff support, monitoring report authoring, trial material development, SOP contributions, and eTMF documentation. The role requires CRA experience, preferably in oncology, hematology, or cell and gene therapy, plus proficiency with clinical trial systems and regulatory requirements.

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.

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 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.

Implement and maintain Orca Bio’s global quality management system across sites. Lead internal audits, supplier qualification and oversight, quality management reviews, inspection readiness, KPI trending, and QMS improvement initiatives. Partner with IT and business owners on electronic QMS enhancements, requirements, prioritization, validation, and compliance. Provide quality oversight for validation documentation and ensure consistent application of GxP and regulatory requirements across global operations.

Own gross-to-net accruals, revenue forecasting, and commercial operating expense planning for a newly commercialized pharmaceutical product. Build accrual methodologies, forecasting models, reserve reconciliations, government pricing calculations, variance analyses, and audit-ready documentation. Partner with Accounting, Market Access, Commercial, auditors, and executive leadership while supporting revenue close, ASC 606 compliance, planning-system implementation, and process automation.

Lead Orca Bios strategic partnership and licensing efforts: source, evaluate, negotiate, execute, and manage collaborations with academia, biotech, and pharma to expand the cell therapy pipeline. Provide scientific and commercial due diligence, build deal structures, advise the C-suite, and align partnerships with regulatory, manufacturing, and commercial strategies to drive value creation.

Own and govern ERP/MES manufacturing master data (materials, BOMs, inventory, vendor records), drive system improvements and UAT, develop functional requirements, ensure GMP compliance, and partner with IT, Procurement, Quality, and vendors to support manufacturing, supply chain, and commercial operations.

Lead and supervise logistics and cold chain teams to ensure secure, compliant, on-time donor cell and drug product movement. Own V2V KPIs, real-time disruption response, cold chain readiness, GMP packing, chain-of-custody, vendor/courier program oversight, capacity planning, and cross-functional coordination with Manufacturing, Quality, and Clinical teams.

Orca Bio invites passionate candidates to join their talent community, focusing on transformative next-generation cell therapies and innovative contributions.