Sr. Specialist Audit Mgt (GXP)

As a key resource within the Audit Management Office (AMO), you will ensure effective coordination and management of audits and inspections involving Data, Digital & IT (DD&IT) systems and processes. This includes supporting GxP audits (e.g., GMP, GCP) and regulatory inspections by authorities such as FDA, EMA, MHRA, and Swissmedic. Your role as an associate will involve acting as a liaison, ensuring that relevant DD&IT subject matter experts address audit queries and deliver required documentation in a timely and accurate manner. Additionally, you will be responsible for monitoring audit findings, overseeing remediations, and driving continuous improvement in audit readiness. Govern processes to effectively manage both internal and external audits across Data, Digital & IT (DD&IT), focusing on GxP (e.g., GMP, GCP), quality, and regulatory-related audits. Act as the single point of contact (SPOC) for audit teams across DD&IT, coordinating audit and inspection activities, ensuring effective communication, and maintaining compliance throughout the process. Notify and mobilize relevant DD&IT stakeholders for audits and inspections, ensuring timely readiness. Coordinate globally with business teams to ensure audit support tickets are created, tracked, and resolved in alignment with Novartis policies and procedures. Conduct pre-audit meetings to clarify IT scope, agree on auditor pre-requests, align timelines, and ensure stakeholders understand expectations for audits and inspections. Provide advice and guidance to DD&IT teams on GxP and information systems compliance requirements to ensure alignment with regulatory standards such as FDA, EMA, MHRA, and Swissmedic expectations. Guide DD&IT SMEs by clarifying audit process requirements and supporting them throughout the audit lifecycle, ensuring accurate delivery of requested information. Collaborate with internal teams to improve and standardize governance frameworks and processes, aiming to reduce audit findings and improve inspection readiness. Manage relationships at a global level across divisions and functions, facilitating cross-functional alignment and collaboration on audit-related matters. Monitor and report on audit findings, remediation actions, and related improvement activities, ensuring compliance, security, and quality gaps are addressed thoroughly. To be considered for this role, you should have a University degree or equivalent, with a Masters degree in IT, Quality Management, Business Administration, or related fields. You should have overall 8-10 years of work experience in quality management, audit, and compliance within IT, preferably in a global organization. Experience in the pharmaceutical industry or other regulated industries, with knowledge of GxP processes and compliance requirements, is required. Strong communication skills and the ability to manage multiple priorities efficiently are essential for this position. Join Novartis and be part of a mission to reimagine medicine and improve people's lives. Learn more about our commitment to diversity and inclusion and explore the opportunities available within our network.,