About

• Company Description
• Transforming Life Science Consulting Worldwide.
• Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health.
• With over 450 employees and 25 offices worldwide, our mission is to revolutionize our clients' business transformation challenges and set new industry standards through innovative solutions.
• Focused on S4HANA, Data & Cloud, and innovative technologies, Fusion Consulting brings unparalleled expertise and commitment to excellence to every project we undertake.
• Grounded in our commitment to fast and intelligent decision-making, our client-first and open-hearted approach defines our ethos. With unwavering support and an entrepreneurial spirit, our global teamwork transcends boundaries and turns shared visions into reality.
• Job Description
• We are seeking a highly experienced Quality Assurance / CSV & Compliance Expert to support a global SAP S/4HANA 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 program’s 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.

What you will be doing

• 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.
• Qualifications
• 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.
• Additional Information

WHY YOU SHOULD JOIN FUSION

• 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.

Joining Fusion means becoming part of a company that

• 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 you to take initiative, solve problems, and lead change.
• Operates with a truly global mindset, where diverse perspectives, cultures, and collaboration fuel our success.
• WHAT WE OFFER - FUSION BENEFITS
• We’ve designed our benefits to support your growth, well-being, and global mobility.
• Growth & Development
• Invest in Your Learning: Access annual training budget for professional development.
• Grow Your Skills: Join regular workshops and trainings to strengthen technical and soft skills.
• Advance Continuously: Build the mindset, confidence, and capabilities to grow your career on your terms.
• Shape an Inclusive Culture: Thrive in a workplace where your individuality is valued, and your voice drives meaningful change.
• Recognition & Reward
• Earn What You’re Worth: Receive a competitive salary and benefits package that reflects your impact.
• Refer Talent: Get rewarded for recommending new hires through our referral program.
• Global Mobility & Local Support
• Navigate Global Moves: Get help with visas, permits, and international assignments.
• Benefit Locally: Enjoy perks tailored to your country of residence.
• Collaborate Globally: Work in a diverse, inclusive culture where global teamwork drives success.

OUR SELECTION PROCESS

Your time is valuable. That’s why our hiring process is clear, efficient, and focused on mutual fit

• Upload Your CV – Submit your application using the relevant button, depending on the job platform (approx. 3 minutes).
• Wait for Profile Review – Our Talent Acquisition team will assess your CV and experience (approx. 2 weeks).
• Join an Introductory Call – Our Talent Acquisition team will arrange a brief conversation (15–30 minutes via Teams or phone) to tell you more about Fusion, the role, and understand your expectations.
• Attend a Technical Interview – Participate in a 30-minute session with one of our experts to discuss your skills and experience in more detail.
• Participate in a Client Interview (if applicable) – For some roles, you may be invited to a client-facing discussion (30–60 minutes online).
• Receive Final Feedback – We aim to share timely feedback and move forward quickly.
• Fusion is an equal opportunity employer. We value diversity and are committed to fostering an inclusive workplace for all.