Consultant - Business Consulting (Life Sciences/Healthcare)

As an Analyst, Consultant, or Senior Consultant at our company, you will have the opportunity to work with a team of high-energy individuals who possess top-notch communication skills, intellectual curiosity, and a passion for excellence. Your role will involve a blend of in-depth domain expertise, strong analytical and conceptual thinking skills, and excellent soft skills. Here are the key responsibilities for this position: - Demonstrated success in roles related to Computerized System Validation, Risk Management, and Audits in the Life Sciences industry - Understanding of key pharmaceutical compliance regulations such as Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX, IT Data Privacy, Data Integrity, and Information Security - Subject matter expertise in Quality Management, document management, and Change Management - Establishing, implementing, and monitoring quality management requirements to ensure IT projects meet Quality and Regulatory standards - Knowledge of Risk management to perform root cause analysis, address deviations, and implement preventive, detective, and corrective measures - Experience in Validation of SAP S4 HANA projects - Conducting periodic control maturity assessments and audits - Familiarity with various Validation tools and templates used in the Pharmaceutical industry - Track record of using Lean Agile approaches to validate assets - Ability to handle multiple large projects, adapt to changing situations, and thrive in complex environments - IT background is preferable to understand the larger impact of architecture and technical complexities on the program - Leading strategic and tactical discussions with senior stakeholders - An MBA, Advanced degree (MS, MPH, PharmD, or PhD) is preferred Additionally, you should have knowledge and experience in Technology, Life Sciences, and Regulatory Systems.,