Job Description

Consultant - SAP S/4HANA Validation Lead (Life Sciences)

We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation for ERP applications like ECC/SAP S/4 HANA, Cloud Validation, Risk management and Quality Management. The candidate will have to perform validation service activities related to ECC to SAP S/4 HANA transformation or SAP implementation program.

Key Responsibilities

1. Own and drive CSV activities for SAP ECC to SAP S/4HANA transformation programs and new SAP implementations.

2. Ensure validation activities comply with regulatory and company quality requirements.

3. Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs.

4. Ensure compliance with 21 CFR Part 11, GxP Regulations, GAMP 5, Data Integrity requirements, Data Privacy regulations, Information Security standards and SOX IT controls

5. Create, review, approve, and maintain-Validation Plans (VP), User Requirements Specifications (URS), Functional & Design Specifications, Risk Assessments, IQ/OQ/PQ documents, Traceability Matrices, Validation Summary Reports (VSR) and SOPs and related quality documents

6. Collaborate with client Quality, Compliance, and Validation teams.

7. Work closely with SAP functional and technical teams across modules such as: Finance (FI/CO), Supply Chain, Manufacturing, Procurement, Quality Management and Master Data Governance (MDG)

Basic Skills & Experience

• Minimum of 3+ years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
• 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
• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, SOX IT, Cloud, S4, Data Privacy, Data Integrity and Information Security
• Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.
• Knowledge on basic function on SAP workstreams/modules
• Knowledge of various tools/applications used in SAP implementation program Like Solution Manager, CHARM, SAP GRC, DRC, SAP MDG, SAP Rise, Data migration tool (SNP, ADM etc.)
• Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time
• Location: Foster City, California

Required Skills & Experience

• Strong understanding of pharmaceutical compliance regulations and validation concepts.
• Experience of having led large S/4 HANA transformation programs from a Validation Lead perspective

Experience with Agile and Waterfall methodologies.

• Familiarity with tools like ServiceNow, JIRA, Veeva, HPALM.
• Ability to manage multiple projects and adapt to complex environments.
• IT background preferred to understand program complexities.
• Excellent communication and collaboration skills.