Principal - Business Consulting

Job Description:

• Infosys stands as a premier global entity in innovative digital services and consulting, boasting annual revenues of $16.31 billion for FY 22.
• We empower clients across 46 countries to successfully embark on their digital transformation journeys.
• Through Infosys Consulting, we collaborate with clients from the initial strategy development phase to execution, facilitating business transformations in areas such as IT strategy, processes, organizational systems, and risk management.
• Our team in Infosys Consulting consists of 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 direction to execution, including operation and optimization of the implemented solutions.
• IC LS is committed to providing specialized services to Life Sciences companies worldwide.

Key Responsibilities:

• We seek individuals who have a proven track record of success in roles focusing on Computerized System Validation, Risk Management, and Audits.
• A minimum of 12 to 20 years of professional experience in the Life Sciences sector, preferably within a consulting services firm or similar industry.
• A solid understanding of essential pharmaceutical compliance regulations, including 21 CFR Part 11, GxP, and GAMP 5.
• Experience in the creation, review, approval, and acknowledgment of validation deliverables.
• Familiarity with risk management processes and quality management requirements to ensure IT projects meet both quality and regulatory standards.
• Hands-on experience with the validation of Enterprise applications such as SAP S4 HANA, Trackwise, QMS, and DMS.
• Functional expertise in various domain applications, including Clinical applications like EDC and CTMS.
• Knowledge of regulatory applications such as CDR, Oracle Argus, ArisGlobal LifeSphere, Veeva Vault, or similar systems utilized in the pharmaceutical industry.
• Deep understanding of compliance and validation principles.
• Experience with Change Control, Deviation, and Supplier Management.
• Familiarity with both Agile and Waterfall methodologies.
• Proficient in conducting periodic or control maturity assessments and audits.
• Knowledge of SaaS Cloud qualifications.
• Experience with validation tools and templates commonly used in the pharmaceutical sector.
• Demonstrated ability to manage multiple projects and respond swiftly to evolving situations within complex environments.
• A preferable IT background to navigate program complexities.

Technical Requirements:

• Infosys stands as a premier global entity in innovative digital services and consulting, boasting annual revenues of $16.31 billion for FY 22.
• We empower clients across 46 countries to successfully embark on their digital transformation journeys.
• Through Infosys Consulting, we collaborate with clients from the initial strategy development phase to execution, facilitating business transformations in areas such as IT strategy, processes, organizational systems, and risk management.
• Our team in Infosys Consulting consists of 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 direction to execution, including operation and optimization of the implemented solutions.
• IC LS is committed to providing specialized services to Life Sciences companies worldwide.

Additional Responsibilities:

• At IC LS, you will
• Be accountable for delivering business outcomes to our global health and life sciences clientele.
• Act as a team member, track lead, or engagement lead on various consulting projects for clients.
• Execute consulting assignments in a global delivery framework, collaborating with consultants across diverse regions.
• Analyze challenges and structure intricate business analyses.
• Engage with cross-functional client teams to conduct gap analyses and pinpoint improvement opportunities.
• Collaborate effectively with both internal and external stakeholders.
• Take part in various firm-building initiatives.

Preferred Skills:

• Domain->Healthcare->Regulatory Compliance & Standards
• Domain->Life Sciences->Pharma Regulations
• Technology->Life Sciences->Regulatory Systems