LS/Principal– SAP Computerized System Validation (CSV)

Infosys•Foster City, CA

11d•Onsite

About The Position

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.

Requirements

Minimum of 12+ 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.
Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of SAP S4 HANA, considering GxP & Non GxP elements and recommend for risk-based testing approach as required.
Work with the Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvements plan to streamline practices, and revise CSV related SOPs as necessary.
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.).
Successful track record using Lean/Agile approaches to validate assets.
Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments.
Ability to pursue and grow deep client relationships.
Provide leadership in critical engagements and drive successful outcomes.
Strong understanding of pharmaceutical compliance regulations and validation concepts.
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.

Nice To Haves

Preferable IT background to understand larger impact of architecture / technical complexities on the program.
Experience of having led large S/4 HANA transformation programs from a Validation Lead perspective.

Responsibilities

Lead Computerized System Validation (CSV) Activities: Own and drive CSV activities for SAP ECC to SAP S/4HANA transformation programs and new SAP implementations. Develop and execute validation strategies, plans, protocols, and reports for GxP and non-GxP systems. Ensure validation activities comply with regulatory and company quality requirements.
Develop Validation Strategy & Risk-Based Approach: Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs. Conduct system risk assessments and determine validation scope. Implement risk-based testing approaches aligned with GAMP 5 and industry best practices.
Ensure Regulatory Compliance: Ensure compliance with 21 CFR Part 11, GxP Regulations, GAMP 5, Data Integrity requirements, Data Privacy regulations, Information Security standards and SOX IT controls. Support audit readiness and inspection preparedness.
Manage Validation Deliverables: 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.
Partner with Quality & Compliance Teams: Collaborate with client Quality, Compliance, and Validation teams. Ensure systems comply with internal policies and health authority requirements. Recommend process improvements and updates to CSV procedures and SOPs.
Support SAP Implementation Workstreams: 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). Assess validation impact of system configuration, enhancements, interfaces, and data migration activities.