Teams at Orca Biotech

Lead payer market access across the Southeast for Orca Bio’s cell therapy products. Develop payer strategies, secure favorable coverage and reimbursement, support treatment-center onboarding, address patient access issues, and build relationships with commercial, Medicare, Medicaid, hospital, and health-system stakeholders. Present clinical and economic value propositions, maintain payer policies, track market access KPIs, and collaborate with Sales, Medical Affairs, Legal, Quality, Marketing, and Case Management. Travel is approximately 40%.

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.