Life Sciences Management Consultant (GRC)

Job Overview:

• Infosys stands as a prominent global authority in advanced digital services and consulting, boasting annual revenues of $16.31 billion for FY 22.
• We assist clients across 46 nations in navigating their digital transformation journeys.
• Infosys Consulting collaborates with clients from the initial strategy phase to execution, transforming their businesses within areas such as IT business strategy, processes, organizational systems, and risk management.
• Our team at Infosys Consulting comprises 2,500 professionals located in the US, Europe, APAC, and India.
• As Value Integrators, we focus on delivering tangible business value by managing transformations from strategic planning to execution, including the operation and optimization of delivered solutions.
• IC LS is committed to supporting Life Sciences companies globally.

Primary Responsibilities:

• We seek motivated, high-energy individuals with exceptional communication skills, intellectual curiosity, and a commitment to excellence.
• Our analysts possess a combination of deep domain knowledge, robust analytical and conceptual thinking abilities, alongside excellent interpersonal skills.
• Ideal candidates will have a proven track record of success in roles focused on Computerized System Validation, Risk Management, and Audits.
• In your role at IC LS, you will:
• Be accountable for delivering business outcomes to clients in the global health and life sciences sectors.
• Act as a team member, track lead, or engagement lead on consulting projects for clients.
• Execute consulting initiatives within a global delivery framework, collaborating with consultants across various regions.
• Analyze challenges and structure intricate business analyses.
• Engage with cross-functional client teams to conduct gap analyses and recommend improvement strategies.
• Work effectively with both internal and external stakeholders.
• Take part in a range of firm-building activities.

Technical Qualifications:

• 4 to 10 years of professional experience in the Life Sciences sector, having worked within a consulting services firm and/or industry.
• Strong understanding of essential pharmaceutical compliance regulations, including 21 CFR Part 11, GxP, and GAMP 5.
• Experience in creating, reviewing, and approving validation deliverables.
• Familiarity with risk management processes and quality management requirements ensuring IT projects meet Quality and Regulatory standards.
• Experience validating enterprise applications such as SAP S4 HANA, Trackwise, QMS, DMS, etc.
• Functional expertise in domain applications such as Clinical applications like EDC and CTMS.
• Knowledge of regulatory applications like CDR or other systems utilized within the pharmaceutical industry.
• Comprehensive understanding of compliance and validation principles.
• Experience with Change Management, Deviation Management, and Supplier Management.

Additional Qualifications:

• Familiarity with validation tools and templates employed in the pharmaceutical sector.
• Proven capability to manage multiple projects and adapt swiftly to evolving situations in complex environments.
• An IT background is preferred to comprehend program complexities.
• Experience with Agile and Waterfall methodologies.
• Hands-on experience in conducting periodic or control maturity assessments and audits.
• Knowledge of SaaS and Cloud qualifications.

Desired Skills:

Technology->Regulatory Compliance->Regulatory Compliance System, Technology->Life Sciences->Regulatory Systems, Domain->Healthcare->Regulatory Compliance & Standards