RESPONSIBILITIES
Infosys 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 closure
- Engage and maintain contacts with key client stakeholders; proactively identify opportunities for business development, and lead workstreams to aid development of new business opportunities
- Provide leadership in critical engagements and drive successful outcomes, and have ability to pursue and grow deep client relationships
- Be a subject matter expert in areas such as Risk Management, Quality Management, Document Management, and Compliance Management
- Understands how key risks and controls have an impact on the business from a pharma, business, operational and/or system perspective
- Demonstrate a clear understanding of the risks and opportunities related to standard operating procedures and the governance policy framework
- Makes recommendations for risk mitigation and audit strategies based on accurate identification of potential market, business, pharmaceutical, operational, IT and talent risks
- Experienced 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 measures
- Experience of working with Risk Management, Security and Compliance Policy frameworks, ISEC & Compliance, Records Management
- Applies an understanding of company short-term and long-term strategic objectives and the risks that apply
- Is knowledgeable about market and regulatory frameworks and trends that have the potential for substantive impact on organization strategies, policies, or risks
- Knowledge and hands on experience conducting periodic or control assessment, audits and risk assessments
- Knowledge of various validation tools and templates used throughout the Pharma and Medical Device industry
- Participate in analyst meetings, industry speaking engagements, publish white papers/view points in leading industry journals
- Participate in practice development activities; coach consultants; participate in consultant training and staffing processes
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
BASIC 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 program
- Experienced in leading strategic and tactical discussions with Senior stakeholders
- MBA, MS or any other advanced degree is preferred
PREFERRED 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 assets
- Experienced in leading strategic and tactical discussions with CxO level
- Industry experiences working directly at pharmaceutical, medical devices or pharma distributor organization is a plus
