Purpose of the position: Provide operational support for the implementation, conduct and oversight of the I/TSS global audit program. This includes the conduct and hosting of audits to ensure compliance in areas of Sarbanes Oxley, GxP, Computer system validation, Privacy, operational information Security.
Your Responsibilities: - Support the hosting of internal and external audits for GxP, ICR/SOX, and Vendors
- Lead and manage the audit readiness activities for internal and external audits
- Participate in the conduct of internal and vendor audits and assessments for GxP, ICR/SOX, and privacy ensuring the integrity, reliability, and quality of processes and systems
- Contribute to the content management for writing SOPs, WIs, Policies for the audit program
- Support implementation and configuration of audit management tools
- Facilitate education and training to the organization on audit program procedures and controls
- Ensuring timely and effective resolution to CAPAs and audit observations related to the audit program
- Partner with audit observation owners to understand root cause analysis and develop appropriate remediation plans
- Provide compliance input to CAPA data reviews to ensure regulatory process adherence
- Support completion of security risk assessments of strategic/operational partners where those partners have access to Business Critical Information.
- Develop a process for management of the Audit mailbox including the coordination and management of activities to provide requested support
- Maintain awareness of new and emerging technologies and regulatory requirements
- Support communications and distribution of final report for external or 3rd party audits
