Consultant - Business (Life Sciences/Healthcare)

What are we looking for?Analysts, Consultants, Senior Consultants We are looking for smart, self-driven, high-energy people with top-notch communication skills, intellectual curiosity and passion for excellence. Our analysts have a blend of in-depth domain expertise, strong analytical and conceptual thinking skills and excellent soft skills. We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation, Risk Management and Audits2 – 14 years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT, Data Privacy, Data Integrity and Information SecuritySubject matter expertise in areas such as Quality Management, document management and Change ManagementEstablish, implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirementsKnowledge of Risk management perform root cause analysis on trends and address deviations via preventive, detective and corrective measuresExperienced in Validation of SAP / S4 HANA projectsKnowledge and hands on experience conducting periodic or control maturity assessment and AuditsKnowledge of various Validation tools and templates used throughout the Pharmaceutical industrySuccessful track record using Lean/Agile approaches to validate assetsProven ability in handling multiple large projects, respond quickly to changing situations in complex environmentsPreferable IT background to understand larger impact of architecture / technical complexities on the programExperienced in leading strategic and tactical discussions with Senior stakeholdersMBA and/or Advanced degree (MS, MPH, PharmD and/or PhD) is preferred