Description ABOUT US: Infosys is a global leader in technology services and consulting. We enable clients in more than 50 countries to create and execute strategies for their digital transformation. From engineering to application development, knowledge management and business process management, we help our clients find the right problems to solve, and to solve these effectively. Our team of 199,000+ innovators, across the globe, is differentiated by the imagination, knowledge and experience, across industries and technologies, that we bring to every project we undertake. RESPONSIBILITIES Infosys Consulting is looking for talented and highly motivated leaders to join our Life Sciences consulting practice. As a Client Engagement Manager, you will work on strategic programs in the area of Compliance helping clients in biopharmaceutical, medical devices and drug distribution sector to develop strategic business capabilities while further deepening your knowledge in in this area.
Lead strategic business transformation programs, manage program planning, execution and reporting; responsible for program resources, deliverables, quality, stakeholder communication, client buy-in, program risks, mitigations and budgets leading to successful program delivery and client delight
Engage with key stakeholders; manage day-to-day interactions with client teams
Conduct interviews/workshops/walkthroughs with subject matter experts and process owners to gather information for analysis, recommendations and for preparation of project deliverables
Participate in sales pursuits in collaboration with larger Infosys teams; contribute to the proposal development process; proposal content creation and client presentation
Develop solutions that enable adoption of digital capabilities for Life Sciences organizations. Participate in analyst meetings, industry speaking engagements, publish white papers/view points in leading industry journals.
Participate in practice development activities; coach junior consultants; participate in consultant training processes.
Travel within the US up to 75% of the time
BASIC QUALIFICATIONS Demonstrates proven success in roles and thorough abilities in one or more of the following areas:
Understanding of key Pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT
Subject matter expertise in areas such as Quality Management, document management and Change Management
Establish, implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
Knowledge of Risk management, perform root cause analysis on trends and address deviations via preventive, detective and corrective measures
Knowledge and hands on experience conducting periodic or control maturity assessment and Audits
Knowledge of various Validation tools and templates used throughout the Pharmaceutical industry
Minimum of 8+ years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
MBA and/or Advanced degree (MS, MPH, PharmD and/or PhD) is preferred
Skilled regulatory background such as 21 CFR part 11, Data Privacy, Data Integrity, Information Security, GxP, and SOX IT knowledge and extensive experience in Project Quality Management
Experienced in Risk Management, Periodic assessments and Audits
Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments
Preferable IT background to understand larger impact of architecture / technical complexities on the program
Successful track record using Lean/Agile approaches to validate assets
Experienced in leading strategic and tactical discussions with Senior Director and Director levels
Industry experience working directly at pharmaceutical, medical devices or pharmaceutical distributor organization (in the space of Compliance) is a plus
Can rewrite 1 point around trends/experience in Automation that is driving compliance and second point around understanding of organizations that are driving innovation in these areas and ripe for partnerships
EOE/Minority/Female/Veteran/Disabled/Sexual Orientation/Gender Identity/National Origin
Associated topics: hematopathology, lab, medical, medical lab science, medical laboratory science, microbiology, mlt, technician ii, technician iv, technologist
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.