Overview
Skills
Job Details
West Point PA
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.
>> Provide strategic direction and governance for SDLC deliverables, leading comprehensive, riskbased quality reviews using the Computer System Assurance (CSA) framework.
>> Define, approve and champion riskbased 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 andor revise SOPs, work instructions and quality documentation coach teams on compliant documentation practices.
>> Lead crossfunctional 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 crossfunctional partnerships.
Requirements:
>> Proven experience with SAP S4HANA or ECC for GxP functionality, including data migration, qualification of migration tools, and interface, reports validation.