- ResponsibilitiesOversee the registration process and manage the internal audit program to ensure inspection readiness, identifying improvements and leading walk-through audits.Lead regulatory inspections, develop remediation and CAPA plans, and ensure timely completion of commitments, while tracking audit data and trends for compliance reporting.Manage external contract service provider and supplier audits, and ensure site regulatory compliance through effResponsibilitiesOversee the registration process and manage the internal audit program to ensure inspection readiness, identifying improvements and leading walk-through audits.Lead regulatory inspections, develop remediation and CAPA plans, and ensure timely completion of commitments, while tracking audit data and trends for compliance reporting.Manage external contract service provider and supplier audits, and ensure site regulatory compliance through eff
- ResponsibilitiesCollaborate with system owners to design and maintain compliant, efficient quality systems supporting GMS and product lifecycle.Oversee data integrity and act as system administrator for key Quality Systems.Manage site Quality System Governance, ensuring compliance with company standards and regulatory requirements.Evaluate, approve, and monitor suppliers, including managing quality agreements.Lead change control processes and handle regulaResponsibilitiesCollaborate with system owners to design and maintain compliant, efficient quality systems supporting GMS and product lifecycle.Oversee data integrity and act as system administrator for key Quality Systems.Manage site Quality System Governance, ensuring compliance with company standards and regulatory requirements.Evaluate, approve, and monitor suppliers, including managing quality agreements.Lead change control processes and handle regula
