Full-Time Quality Assurance / CSV & Compliance Expert

• Own and govern the Quality & Compliance Framework for the S/4HANA program, ensuring alignment with GxP, CSV, 21 CFR Part 11, data integrity principles, and internal quality standards.
• Serve as the primary compliance authority for all quality-related and regulatory questions across program teams, business stakeholders, and external partners.
• Define, maintain, and enforce validation methodologies (including agile, hybrid, and cloud delivery models) ensuring they meet regulatory expectations in a life sciences environment.
• Oversee and approve QA strategies, test approaches, validation plans, and documentation standards, ensuring consistency, traceability, and audit readiness.
• Provide governance and oversight for test strategy, test planning, test execution, and defect management, ensuring alignment with CSV and GAMP best practices.
• Ensure that all program deliverables, documents, and testing evidence comply with regulatory standards and align with the validated state of the system.
• Collaborate with SAP functional teams, data migration, security, and technical workstreams to ensure end-to-end compliance coverage across all processes and system components.
• Support and guide test automation initiatives, ensuring automation frameworks and outputs comply with GxP and validation requirements.
• Provide training, coaching, and continuous guidance on QA, CSV, and compliance expectations across the program.
• Monitor quality risks, raise issues proactively, and drive remediation actions to maintain a validated and compliant implementation landscape.

• 5+ years of experience in Quality Assurance, CSV, or Compliance roles within large-scale IT or ERP programs in the life sciences industry.
• Demonstrated experience governing GxP-relevant S/4HANA or SAP transformations, with a strong understanding of regulated business processes.
• Deep expertise in CSV, GAMP 5, 21 CFR Part 11, Annex 11, data integrity, and other global regulatory frameworks.
• Proven ability to design and manage validation approaches in agile, cloud, and hybrid program environments.
• Strong working knowledge of SAP platforms, end-to-end business processes, and associated risk and control frameworks.
• Hands-on experience with test management and quality tools, such as ALM, Jira, SAP Solution Manager, Tricentis Tosca, or equivalents.
• Exceptional analytical, documentation, and communication skills, with the ability to influence diverse stakeholders and maintain high compliance standards.
• Bachelor’s degree in Life Sciences, Computer Science, Information Systems, Engineering, or related field. Relevant certifications (e.g., GAMP, ISTQB, SAP QA tools) are a strong plus.

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