Lead Validation & Test Manager – Pharma Life Sciences
Share
Job Location:
Frankfurt am Main - Germany
Monthly Salary:
Not Disclosed
Posted on:
7 days ago
Vacancies:
1 Vacancy
Job Summary
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 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 :
- Bachelors/Masters 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 worlds 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
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
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 em ... View more
