Senior Principal - Business Consulting (Risk & Advisory)

RESPONSIBILITIESInfosys Consulting is looking for talented and highly motivated consultants to join our Life Sciences consulting practice. As a Senior Principal, you will work on strategic programs in the Life Sciences risk and compliance / advisory areas helping pharma, biopharma and medical devices companies develop strategic business capabilities while further deepening your knowledge in this area.Lead Pre-Sales and Sales activities including Proposal Development, Solution and Value Proposition; in collaboration with larger Infosys teams, lead proposal development process; solution formulation; proposal pricing; client presentation; contract negotiations and deal closureEngage and maintain contacts with key client stakeholders; proactively identify opportunities for business development, and lead workstreams to aid development of new business opportunitiesProvide leadership in critical engagements and drive successful outcomes, and have ability to pursue and grow deep client relationshipsBe a subject matter expert in areas such as Risk Management, Quality Management, Document Management, and Compliance ManagementUnderstands how key risks and controls have an impact on the business from a pharma, business, operational and/or system perspectiveDemonstrate a clear understanding of the risks and opportunities related to standard operating procedures and the governance policy frameworkMakes recommendations for risk mitigation and audit strategies based on accurate identification of potential market, business, pharmaceutical, operational, IT and talent risksExperienced with planning and conducting functional and domain specific risk assessment of Pharma and Medical Device programs / projects Experienced in using industry wide risk management tools, and to perform root cause analysis on trends and address deviations via preventive, detective and corrective measuresExperience of working with Risk Management, Security and Compliance Policy frameworks, ISEC & Compliance, Records ManagementApplies an understanding of company short-term and long-term strategic objectives and the risks that applyIs knowledgeable about market and regulatory frameworks and trends that have the potential for substantive impact on organization strategies, policies, or risksKnowledge and hands on experience conducting periodic or control assessment, audits and risk assessmentsKnowledge of various validation tools and templates used throughout the Pharma and Medical Device industryParticipate in analyst meetings, industry speaking engagements, publish white papers/view points in leading industry journalsParticipate in practice development activities; coach consultants; participate in consultant training and staffing processesAI Risk AssuranceConduct comprehensive risk assessments of AI applications, including data integrity, model performanceEnsure that AI systems comply with relevant regulations and standards, such as FDA guidelines, ISO standards, and GDPR, while keeping abreast of evolving regulations in the AI landscapeDevelop and implement risk assurance frameworks and methodologies specific to AI technologies in life sciences, ensuring alignment with organizational policies and industry best practicesCollaborate with cross-functional teams, including data scientists, IT, compliance, and legal departments, to identify and mitigate AI-related risks throughout the product lifecycleLead training sessions and workshops to enhance awareness of AI risk management among employees and stakeholders, fostering a culture of responsible AI useEstablish metrics and monitoring systems to track AI risk factors and report findings to senior management and relevant regulatory bodiesStrong understanding of AI technologies, machine learning algorithms, and their applications in Life Sciences spaceControl integration & testingLead the design, development, and implementation of control integration systems for Life Sciences applicationsCollaborate with clients to understand their requirements and provide expert guidance on control systems architecture, configuration, and integrationEnsure compliance with regulatory standards such as FDA, GxP, and ISO, and maintain documentation to support audits and inspectionsConduct risk assessments and develop mitigation strategies for control integration projectsSOX Compliance & TestingLead the planning, execution, and reporting of SoX compliance activities for life sciences clientsDevelop and maintain SoX compliance frameworks, policies, and procedures in accordance with regulatory requirementsCollaborate with cross-functional teams to identify and assess risks related to financial reporting and internal controlsDesign and implement testing strategies to evaluate the effectiveness of internal controls and compliance processesConduct detailed testing of controls and document findings, recommendations, and remediation plansMonitor and track the progress of remediation efforts and ensure timely resolution of identified deficienciesProvide guidance and support to clients in understanding SoX requirements and best practicesBASIC QUALIFICATIONS (candidates without these need not apply)Demonstrates proven success in roles and thorough abilities in one or more of the following areas:Minimum of 18+ years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.Preferable IT background to understand larger impact of business, organization mission and strategies, architecture / technical complexities on the programExperienced in leading strategic and tactical discussions with Senior stakeholdersMBA, MS or any other advanced degree is preferredPREFERRED QUALIFICATIONS (ideal candidates will have these advantages)Successful track record using industry leading tools and techniques to conduct risk assessments and compliance checks to build digital solutions in a multi-disciplinary, multi-vendor corporate setting, and to validate assetsExperienced in leading strategic and tactical discussions with CxO levelIndustry experiences working directly at pharmaceutical, medical devices or pharma distributor organization is a plus

Apply Now