Job Description

• 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.

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