Lead Validation & Test Manager – Pharma / Life Sciences

Fusion Consulting; Frankfurt; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A leading consulting firm is actively seeking a highly skilled Lead Validation & Test Manager to join their team in Frankfurt, Hesse. In this role, you will lead validation and testing activities across a portfolio of regulated systems, ensuring compliance with global regulatory standards. You will oversee governance for testing frameworks, mentor professionals, and manage CAPA processes. Ideal candidates should possess a Bachelor's or Master's degree and over 7 years of experience in GxP regulated industries, coupled with strong leadership and stakeholder management capabilities.

Qualifikationen

• 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.

Aufgaben

• Establish and maintain validation and testing governance.
• Oversee validation and testing across SAP and GxP systems.
• Drive CAPA management and root cause analysis for compliance issues.

Kenntnisse

Leadership

Stakeholder management

Communication

Risk-based validation

Quality compliance

Ausbildung

Bachelor’s/Master’s in Life Sciences, IT, Engineering or related field

Tools

SAP (S/4HANA, SolMan, Cloud ALM)

Tricentis Tosca/Q-Test

Veeva Vault

Jira/ALM

BPMN 2.0

Jobbeschreibung

• Full-time

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 management and communication skills.
• Fluent English; German is a strong plus.