Lead Validation

Company Description

Swiss Delivery Excellence: 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 skilled and motivated Lead Validation & Test Manager to lead validation and testing activities across a portfolio of regulated systems and digital transformation initiatives. In this role, you will be responsible for defining, managing and optimizing validation and testing frameworks for SAP and GxP systems, ensuring full compliance with global regulatory standards (FDA, EMA, etc.). This position requires a strong balance of strategic leadership, technical expertise and operational oversight across global programs. It spans computer system validation (CSV), process validation and qualification activities, ensuring full traceability and adherence to GxP and global regulatory standards.

• Establish and maintain validation and testing governance aligned with GxP, GAMP 5 and corporate quality standards.
• Oversee and coordinate validation and testing (e.g. end-to-end testing) across SAP, GxP and digital systems, whilst ensuring consistency, quality and compliance throughout.
• Apply risk-based approach to validation and testing scope definition and execution.
• Drive CAPA management, deviation investigations and root cause analysis for validation/test failures or compliance issues.
• Serve as a central point of contact for all validation and compliance-related activities within the project lifecycle.
• Mentor validation and testing professionals, fostering a culture of quality, compliance, and best practice adoption.

Tools & Technologies

SAP (S/4HANA, SolMan, Cloud ALM) · Tricentis Tosca/Q-Test · Kneat · Veeva Vault · Jira/ALM · Signavio · BPMN 2.0 · Other industry-recognized validation and testing tools

Qualifications

• Bachelor's/Master's in Life Sciences, IT, Engineering or related field.
• 7+ years in validation, testing or QA within GxP regulated industries.
• Experience with SAP transformation / enhancement projects.
• Deep understanding of GxP, CSV, GAMP 5, ISO standards, 21 CFR Part 11, Annex 11.
• Strong leadership, stakeholder managementand communication skills.
• Fluent English; German is a strong plus.

Additional Information

At Fusion, we aspire to be one of the world's leading life sciences consulting firms, setting industry benchmarks with innovative and pioneering solutions.

At Fusion, we unite entrepreneurial minds from around the globe to develop and implement game-changing solutions that build lasting relationships with our clients.

Hiring Philosophy: We value employees who push boundaries through innovation, navigating diverse client needs in ever-evolving environments, with a commitment to continuous learning both for themselves and their colleagues.

Growth & Development: Go beyond, grow beyond, and maximize impact. Each employee shapes their own journey, and our mission is to ignite the spark of greatness while pushing the boundaries of what you are capable of. We cultivate an environment where every individual can thrive and flourish through meaningful connections, extended learning, motivation, and support to experiment with new and innovative approaches, including taking risks.

Feedback Culture: We emphasize and promote continuous, real-time feedback across all levels. We see feedback as providing individuals with the information and tools they need to develop their strengths and overcome challenges. Feedback is a gift, and inspiring individuals is our competitive advantage

Shape you own journey - How far will you take yourself?