Quality Assurance / CSV & Compliance Expert at Fusion Consulting

Lisbon, , Portugal -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

0.0

Posted On

08 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, CSV, Compliance, GxP, SAP S/4HANA, Validation Methodologies, Test Management, Data Integrity, Agile, Cloud, GAMP 5, 21 CFR Part 11, Documentation, Analytical Skills, Communication Skills, Stakeholder Management

Industry

IT Services and IT Consulting

Description

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.

Responsibilities

The role involves owning and governing the Quality & Compliance Framework for the S/4HANA program, ensuring alignment with regulatory standards. Additionally, the expert will oversee QA strategies, test approaches, and documentation standards to maintain compliance and audit readiness.