Senior SAP S/4HANA CSV Lead – Life Sciences

Infosys; Foster City (CA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical/Dental/Vision/Life Insurance

Long-term/Short-term Disability

401(k) plan

Job summary

Infosys Consulting in the United States is seeking a Consultant – SAP S/4HANA Validation Lead for Life Sciences to drive CSV activities across ECC to SAP S/4HANA transformations and new SAP implementations.

You will define validation frameworks, ensure compliance with 21 CFR Part 11, GxP and data integrity, and collaborate with client Quality, Compliance and Validation teams while coordinating with SAP modules like FI/CO, QM, MDG. This full-time role is based in Foster City, CA.

Qualifications

• Minimum 3+ years in Life Sciences with consulting or industry experience.
• Experience creating, reviewing and approving validation deliverables.
• Knowledge of risk management and quality requirements for IT projects.
• Understanding of 21 CFR Part 11, GxP, GAMP 5, SOX IT, Cloud and Data Privacy.
• Ability to build integrated CSV project plans with validation deliverables.
• Familiar with SAP workstreams/modules.
• Authorized to work in the US without visa sponsorship.

Responsibilities

• Own and drive CSV activities for SAP ECC to SAP S/4HANA transformation programs and new SAP implementations.
• Ensure validation activities comply with regulatory and company quality requirements.
• Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs.
• Ensure compliance with 21 CFR Part 11, GxP Regulations, GAMP 5, Data Integrity, Data Privacy and SOX IT controls.
• Create, review, approve, and maintain VP, URS, FDS/Design Specs, Risk Assessments, IQ/OQ/PQ, VSRs and SOPs.
• Collaborate with client Quality, Compliance, and Validation teams.
• Work with SAP teams across FI/CO, SCM, QM, MDG; manage multiple projects.

Skills

Project management

Regulatory compliance

Life Sciences experience

Validation deliverables

Tools

Solution Manager

CHARM

SAP GRC

DRC

MDG

SAP Rise

Data migration tools

Job description

Infosys Consulting in the United States is seeking a Consultant – SAP S/4HANA Validation Lead for Life Sciences to drive CSV activities across ECC to SAP S/4HANA transformations and new SAP implementations.

You will define validation frameworks, ensure compliance with 21 CFR Part 11, GxP and data integrity, and collaborate with client Quality, Compliance and Validation teams while coordinating with SAP modules like FI/CO, QM, MDG. This full-time role is based in Foster City, CA.