Life Sciences Management Consultant - Governance, Risk and Compliance

Infosys; Bengaluru; On-site; INR 1,500,000 - 2,400,000; Full time

Job summary

IC-LS in India is seeking a Life Sciences Management Consultant (GRC) with 4–14 years of experience in pharma compliance, validation, and regulatory programs. You will deliver business results for global health and life sciences clients and lead engagements.

You will analyze problems, perform gap analyses, and work with cross-functional teams to drive improvements, audits, and risk management across SAP/S4HANA, Trackwise, QMS, and DMS ecosystems.

Qualifications

• 4–14 years of professional experience in Life Sciences within a consulting service organization or industry
• Strong understanding of pharmaceutical compliance regulations (e.g., 21 CFR Part 11, GxP, GAMP 5)
• Experience creating, reviewing and approving validation deliverables
• Knowledge of risk management processes and quality management for IT projects
• Experience validating enterprise applications (e.g., SAP/S4HANA, Trackwise, QMS, DMS)
• Functional knowledge of clinical/regulatory applications (EDC, CTMS, CDR)
• Awareness of validation concepts (Change, Deviation, Supplier management)
• Knowledge of validation tools and templates used in pharma
• Ability to support multiple projects and adapt to complex environments
• IT background beneficial; familiar with Agile and waterfall methodologies
• Experience conducting periodical/control maturity assessments and audits
• Knowledge of SaaS/Cloud qualifications

Responsibilities

• Be responsible for delivering business results to global health and life sciences clients
• Serve as a team member, track lead or engagement lead on consulting engagements
• Execute engagements in a global delivery model across regions
• Analyze problems and structure complex business analyses
• Work with cross-functional client teams to perform gap analyses and identify improvements
• Collaborate with internal and external stakeholders effectively
• Participate in firm-building events

Skills

Pharma compliance

Validation

GxP

21 CFR Part 11

Risk management

Audits

Agile / Waterfall

CPSV / CSV

Cloud/SaaS qualifications

Tools

SAP

S/4HANA

Trackwise

QMS

DMS

Job description

Life Sciences Management Consultant - (GRC)

• 4 – 14 years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry.
• Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5.
• Experience creating, reviewing and approving / acknowledging validation deliverables.
• Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
• Experience in validation of Enterprise applications such as SAP / S4 HANA projects, Trackwise, QMS, DMS and etc.
• Functional knowledge in any of the domain applications such as Clinical applications like EDC, CTMS etc., Regulatory applications like CDR, or any other applications/system used in Pharma industry.
• Thorough Knowledge in compliance and validation concepts. (Change, Deviation, Supplier management)
• Knowledge of validation tools and templates used in the pharmaceutical industry.
• Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments.
• Preferable IT background to understand complexities on the program.
• Experience in Agile and waterfall methodology
• Knowledge and hands on experience in conducting periodic or control maturity assessment and Audits
• Knowledge in Saas/Cloud Qualifications

We are looking for smart, self-driven, high-energy people with top-notch communication skills, intellectual curiosity and passion for excellence. Our analysts have a blend of in-depth domain expertise, strong analytical and conceptual thinking skills and excellent soft skills. We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation, Risk Management and Audits

At IC-LS, you will:

• Be responsible for the delivery of business results to global health and life sciences clients.
• Serve as a team member, track lead or engagement lead on business consulting engagements for clients.
• Execute consulting engagements in a global delivery model, working with consultants across regions.
• Analyze problems, and structure complex business analyses.
• Work with cross functional client teams to perform gap analysis and identify improvement options.
• Effectively collaborate with the internal and external stakeholders.
• Participate in a variety of firm building events