Opportunity Description
Contribute to establishing the strategic direction of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan. Plan, lead, conduct, document, and follow-up of GMP audit according to the requirements specified in the respective Novartis Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents. For this expert role, the leader in this position is able to audit complex and high-risk sites and activities. The leader in this position is considered an expert and SME in one or more manufacturing areas, such as sterile manufacturing, combination products, biologics, etc. Provide technical guidance, mentoring, and training on audit activities. Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing. Prepare audit reports according to NVS requirements and timelines. Ensure appropriate escalation to responsible...