- Plan, schedule and execute internal audits across all sites and functions in accordance with the internal audit program.
- Develop audit agenda, conduct interviews, review processes and generate audit reports.
- Support the global Quality Management Review (QMR) process, ensuring timely data collection, analysis, and reporting to senior leadership.
- Support the supplier qualification and management program, including risk assessments, supplier audits, and ongoing monitoring to ensure compliance with GxP requirements.
- Drive global inspection management activities, ensuring cross-functional and site readiness for FDA, EMA, and other health authority inspections.
- Provide oversight and guidance to site QMR administrators ensuring consistent quality system implementation across all Orca Bio sites.
- Establish and monitor global QMS key performance indicators (KPIs), oversee trending of quality metrics, and ensure data-driven insights are used to improve quality systems and performance.
- Partner with IT and business process owners to identify and implement QMS system enhancements, including defining requirements, driving prioritization and ensuring changes are validated and compliant.
- Review, approve, and provide quality oversight for validation documentation (e.g., equipment qualification, computer system validation, process validation) for global enterprise systems ensuring alignment with regulatory and internal requirements.
- Collaborate with cross-functional and site leadership teams to drive continuous improvement initiatives, ensuring the QMS evolves in line with business needs and regulatory expectations.
Quality Assurance