About the Company
Who are we Infosys is a global leader in next-generation digital services and consulting with annual revenues of $16.31B (FY 22). We enable clients in 46 countries to navigate their digital transformation. Infosys Consulting partners with clients from strategy through execution to transform their businesses in areas such as business/ IT strategy, processes, organization, systems and risk. Infosys Consulting has 2,500+ people across the US, Europe, APAC and India. We are Value Integrators – we deliver realized business value by managing transformations from strategy / setting direction through execution, including operating and optimizing delivered solutions. IC-LS is dedicated to serving Life Sciences firms globally.
About the Role
What are we looking for We are looking for smart, self-driven, high-energy people with top notch communication skills, intellectual curiosity and passion for ethics and compliance management as Risk & Compliance experts particularly in Life Sciences with the majority experience in consulting roles at a Tier 1 IT company or Big 4/management consulting firm. Our consultants have a blend of in-depth domain expertise in one or more areas of Life sciences, strong business consulting skills and excellent soft skills.
Responsibilities
- Domain Specific skills: Subject Matter Expert in either one of the following - AI Risk Management / Monitoring / Assurance, Control Integration & Testing, SoX Compliance & Testing
AI Risk Assurance-
- Conduct comprehensive risk assessments of AI applications, including data integrity, model performance.
- Ensure 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 landscape.
- Develop and implement risk assurance frameworks and methodologies specific to AI technologies in life sciences, ensuring alignment with organizational policies and industry best practices.
- Collaborate with cross-functional teams, including data scientists, IT, compliance, and legal departments, to identify and mitigate AI-related risks throughout the product lifecycle.
- Lead training sessions and workshops to enhance awareness of AI risk management among employees and stakeholders, fostering a culture of responsible AI use.
- Establish metrics and monitoring systems to track AI risk factors and report findings to senior management and relevant regulatory bodies.
- Strong understanding of AI technologies, machine learning algorithms, and their applications in Life Sciences space.
Control Integration & Testing-
- Lead the design, development, and implementation of control integration systems for Life Sciences applications.
- Collaborate with clients to understand their requirements and provide expert guidance on control systems architecture, configuration, and integration.
- Ensure compliance with regulatory standards such as FDA, GxP, and ISO, and maintain documentation to support audits and inspections.
- Conduct risk assessments and develop mitigation strategies for control integration projects.
SOX Compliance & Testing-
- Lead the planning, execution, and reporting of SoX compliance activities for life sciences clients.
- Develop and maintain SoX compliance frameworks, policies, and procedures in accordance with regulatory requirements.
- Collaborate with cross-functional teams to identify and assess risks related to financial reporting and internal controls.
- Design and implement testing strategies to evaluate the effectiveness of internal controls and compliance processes.
- Conduct detailed testing of controls and document findings, recommendations, and remediation plans.
- Monitor and track the progress of remediation efforts and ensure timely resolution of identified deficiencies.
- Provide guidance and support to clients in understanding SoX requirements and best practices.
General skills:
- Overall experience of 15+ years, with at least 2+ years of top-tier consulting experience post MBA in programs / projects with Lifesciences/ Healthcare clients.
- Skilled regulatory background such as 21 CFR part 11, Data Privacy, Data Integrity, Information Security, GxP, and SOX IT knowledge.
- Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments.
- Experienced in leading strategic and tactical discussions with Senior Director and Director levels.
- Is knowledgeable about market and regulatory trends that have the potential for substantive impact on organization strategies, policies, or risks.
- Ability to handle conversations with senior business and technology leaders from client teams.
- Ability to build engaging client presentations (Expertise on MS PowerPoint, MS Word, MS Excel, MS Project).
- Appreciation for IT's role in enabling business processes and growth.
- Appreciation and understanding of Disruptive digital technologies.
What do we require
- Be responsible for the delivery of business results to global pharmaceutical, medical devices and pharmaceutical distributors.
- Serve as a team member, track lead or engagement lead on business consulting engagements for clients. Execute or lead consulting engagements in a global delivery model, working with consultants across regions.
- Lead / contribute to sales pursuits, consulting offerings and internal initiatives. Analyze problems, and structure complex business analyses.
- Perform Business Process Improvement using various business consulting tools and methodologies.
- Work with cross functional client teams to perform gap analysis and identify improvement options.
- Create detailed action plans that include organizational change management, resource planning, competitive strategies, and alliances to embark on a new strategic direction and to enable successful deployment of solutions.
- Lead client workshops to collaborate with client employees and educate them throughout the process.
- Participate in a variety of Firm building events and the consultant referral program. Build deep industry experience with thought leadership.
Where are we hiring Anywhere in India
