Quality Assurance CSV & Compliance Expert

We are seeking a highly experienced Quality Assurance / CSV & Compliance Expert to support a global SAP S/4

HANA transformation program within the regulated life sciences sector. This role serves as the single source of truth for all GxP and compliance‑related matters ensuring that the programs quality framework delivery methodologies documentation and testing processes consistently meet regulatory expectations. You will provide overarching governance, ensure audit‑ready documentation and drive a compliant approach to agile cloud and implementation practices across the program.

• Own and govern the Quality & Compliance Framework for the S/4
  
  HANA 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 work streams 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/4
  
  HANA 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.
• Bachelors 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.

At Fusion you’ll join a diverse team of talented professionals from around the world united by a passion for delivering impactful digital transformation in the life sciences industry. You’ll be part of a flat‑structured collaborative organization where decisions are made efficiently and your expertise directly shapes client outcomes.

You’ll work alongside experienced consultants on complex meaningful projects that demand both precision and innovation. Our culture emphasizes continuous learning, open knowledge sharing and cross‑functional teamwork empowering you to grow both professionally and personally.

• Builds strong trusted partnerships with clients delivering tailored solutions that create real business value.
• Drives delivery excellence holding ourselves accountable for the quality and impact of every outcome.
• Encourages entrepreneurial thinking empowering…