Senior Validation - Frankfurt, Hesse

Nur für registrierte Mitglieder Frankfurt, Hesse, Deutschland

vor 1 Tag

77.000 € - 108.000 € (EUR) pro Jahr

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 ...

Jobbeschreibung

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 an experienced and driven
Senior Validation & Test Manager
to lead validation and testing across SAP implementations, upgrades and digital transformation initiatives. In this role, you will define and implement validation strategies, manage testing activities and ensure full compliance with GxP and global regulatory standards (FDA, EMA, etc.) throughout the project lifecycle. The position covers computer system validation (CSV), process validation / qualification activities, whilst ensuring complete traceability and regulatory adherence.

Develop and implement validation and test strategies (incl. validation documentation) aligned with project goals, regulatory standards and quality policies.
Ensure all validation deliverables adhere to good documentation practices (GDP) and are audit-ready in accordance with GAMP 5, ISO standards (ISO 27001, ISO 9001) and relevant FDA/EMA regulatory guidelines.
Oversee validation and testing activities (e.g. end-to-end testing) across systems, processes and platforms including SAP, GxP systems and digital platforms.
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

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.
5+ years in validation/testing within GxP-regulated environments.
Strong understanding of CSV, GAMP 5, 21 CFR Part 11, Annex 11, ISO 9001/27001.
Experience with SAP transformation / enhancement projects.
Excellent communication and stakeholder engagement 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?