Position Details
Compliance Lead Gxp S Hana Implementation Apply
| Primary & Secondary Skill | Compliance Lead, S/4HANA implementation experience |
| JD (Detailed) | Provide quality oversight for GxP computerized systems across programs, including ownership of audit and inspection support and remediation activities and ensure compliance with company policies, procedures, and regulatory expectations. Required: Proven experience with SAP S/4HANA or ECC for GxP functionality, including data migration, qualification of migration tools, and interface, reports validation. Provide strategic direction and governance for SDLC deliverables, leading comprehensive, risk based quality reviews using the Computer System Assurance (CSA) framework. Define, approve and champion risk based validation strategies and test plans for functional and regression testing. Lead root cause analysis and investigations for IT system incidents, drive CAPA development and ensure timely closure and verification. Serve as subject-matter lead on Data Integrity: interpret guidance, direct remediation activities, and ensure lasting controls are implemented. Drive testing strategy and quality practices within Agile teams; represent quality in Scrum ceremonies and ensure quality requirements are embedded from inception. Oversee review and approval of IT system change requests, ensuring appropriate documentation, traceability and regulatory compliance. Authorize and/or revise SOPs, work instructions and quality documentation; coach teams on compliant documentation practices. Lead cross functional meetings to resolve compliance issues, escalate as needed, and ensure timely resolution of document comments and findings. Act with independence, objectivity and accountability; mentor quality staff and foster collaborative, innovative cross functional partnerships. |
