Validation SME

Job Title: Validation SME [IT CSV for SAP Application]

Location: Foster City, CA (Hybrid)

Job Details:

The identified candidate will support a large S/4 HANA transformation program from a validation SME perspective.

Below are the role expectations:

• 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
• Preferable IT background to understand larger impact of architecture / technical complexities on the program

Minimum Years of experience: 10+ Years