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Lead Validation & Test Manager – Pharma / Life Sciences
Résumé du poste
A consulting firm in Germany is seeking a highly skilled Lead Validation & Test Manager to oversee validation and testing across regulated systems. Responsibilities include managing governance aligned with GxP and corporate quality standards, coordinating testing across SAP and digital systems, and mentoring professionals in the field. The ideal candidate should have over 7 years of experience in validation within GxP regulated industries, a degree in Life Sciences or related fields, and strong leadership skills.
Qualifications
- 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.
Responsabilités
- Establish and maintain validation and testing governance.
- Oversee and coordinate validation and testing across systems.
- Drive CAPA management and root cause analysis.
Connaissances
Formation
Outils
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.
- 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
- 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 management and communication skills.
- Fluent English; German is a strong plus.
* Le salaire de référence se base sur les salaires cibles des leaders du marché dans leurs secteurs correspondants. Il vise à servir de guide pour aider les membres Premium à évaluer les postes vacants et contribuer aux négociations salariales. Le salaire de référence n’est pas fourni directement par l’entreprise et peut pourrait être beaucoup plus élevé ou plus bas.