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Heres What Youll Do Provide validation strategy and management oversight for the global implementation of SAP Transformation Develop and document the validation strategy and approach of the Software Development Lifecycle Activities (SDLC) for the global implementation of SAP S4 Hana, considering GxP & Non GxP elements. Accountable for the creation and management of key validation documents: Validation Plan, Data Migration Plan and Summary Reports (Migration, Testing & Summary) and provide support and review/approval of Specifications, Testing Documentation (Plans, Test Protocols, Test Cases & Scripts), Trace Matrix etc. according to clients SDLC. Coordinate and oversee the development of Risk Analysis and Functional Risk Assessment(s 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. Project manage and maintain the schedule for the required CSV Lifecycle Deliverables to ensure schedule adherence and deliverable closure to support Program Odyssey. Provide weekly and or daily status update of progress against plan, testing status, risks and issues. Work with the Quality organization to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations. Create a validation training program(s) for Program Odyssey working with additional validation team members as needed to enable System Integrator (SI) resources and Moderna project team members achieve compliance. Oversee execution of the plan working with additional validation team members to ensure compliance and course correction as needed to maintain compliance. Oversee and provide direction to additional validation team members. Support Go-Live readiness and hyper-care change control related validation needs. Liaise and collaborate with Digital Compliance on CSV process definition and improvements to streamline practices, and revise CSV related SOPs as necessary. Demonstrate and apply knowledge of regulations (e.g., FDA 21 CFR Part 11, 211, 820; EudraLex Annex 11, SOX, Disaster Recover) and guidance (e.g., FDA, GPSV, ICH, PIC/S), and industry best practices (e.g., ISPE, GAMP 5 Heres What Youll Need (Minimum Qualifications) 10+ years of Computer System Validation experience implementing and maintaining ERP - SAP technology (SAP S4Hana) to support compliance processes in a regulated biotech or Pharma company. Large Scale Global Implementations is a plus. Experience with SAP S4Hana, Solution Manager, Veeva Quality Vaults (eDMS and eQMS), SAP SuccessFactors Learning Management, KneatGx Validation Management System, ServiceNow, or similar technologies. API, data report development and systems integration Heres What Youll Bring to the Table (Preferred Qualifications) Excellent interpersonal and communication skills with ability to work collaboratively within a team of cross functional stakeholders to influence decisions Quality orientated with strong attention toward detail Self-directed with effective analytical and problem-solving skills to make sound and timely decision to achieve expected results Ability to navigate through ambiguity and rapid growth and adapt to change Ability to react under pressure to any given situation that may arise, in a professional manner and with positive results, in support of a multi-location, 24x7 environment. Ability to work hard to effect change in a dynamic, high standards environment while maintaining a positive approach with management and peers. Highly collaborative work style. Strong interpersonal skills with the ability to build successful professional working relationships. Ability to work effectively in a cross-functional, fast-paced project environment. Working knowledge of relevant FDA, EU, ICH guidelines and regulations related to computer systems SOX, CSV, data integrity Technical writing skills required