Global Business Applications CSV and Test Management Lead

Straumann Group

Ourense

Hybrid

EUR 90,000 - 120,000

Full time

14 days+

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Job summary

Straumann Group seeks an experienced CSV and Test Management Lead to drive validated software solutions (SAP, Salesforce, and other enterprise apps) and enable global Test Management for the Global Business Applications department. The role requires deep CSV and Test Management expertise for enterprise applications and regulatory compliance.

Based in Europe, you will collaborate with IT, QA, and business stakeholders to ensure compliant delivery of major initiatives, including S/4HANA, with a

Qualifications

10+ years in CSV, QM, Test and PM with leadership experience.
GxP, 21 CFR Part 11, GAMP5 and Annex11 familiarity for validated systems.
Experience with enterprise applications (SAP, Salesforce) and IT validation.

Responsibilities

Lead validation documentation across SDLC with stakeholders.
Provide CSV guidance to project teams and ensure compliance.
Drive continuous CSV improvements aligned with IT and QA.
Define and implement Test Management for major ERP initiatives like S/4HANA.

Skills

CSV leadership

Test management

GxP compliance

SAP expertise

Salesforce

Validation docs

Stakeholder mgmt

Project management

Regulatory knowledge

Education

Bachelor's or Master's in CS/IS/QM

Tools

SAP

Salesforce

Job description

Job Purpose

This is a great opportunity to apply your leadership and expertise in pursuit of our mission to become the most customer-focused and innovative oral care company in the world. We are seeking an experienced CSV and Test Management Lead to drive the delivery of validated software solutions like SAP, Salesforce and other enterprise Applications and enable Global Test Management and capabilities for Straumann’s Global Business Applications department. The ideal candidate will bring deep CSV and Test Management expertise for Enterprise Business Applications like SAP, etc.

Main Tasks And Responsibilities

Manage and review all levels of validation documentation (internal or external SDLC) in collaboration with all stakeholders, including Validation (Strategy) & Test Plans, User Requirements, Functional, Configuration, Installation Specifications, SOP’s and Qualification Documents like Test Specifications & records, Traceability Matrices, Risk Analysis, Validation Reports, etc.
Provide implementation or update project teams with computerized systems validation (CSV) guidance
Continuous Improvement of CSV standards, considering best practices and regulatory changes to maintain compliance and improve validation processes in alignment with IT and QA departments.
Key role for defining, driving and implementation of Test Management for Business Application and other major initiatives like S/4HANA in alignment with Application Lifecycle Management Strategy
Partner with Quality Assurance, Test Management and Compliance teams to align deliverables as CSV guidelines
Coordinate local CSV and QA representatives to fulfill global CSV Compliance requirements.
Provide Training, guidance and coaching to all stakeholders for CSV standards, Test approaches
Collaborate with functional teams in IT across SAP and other Business Application stakeholders and all relevant business representatives to ensure compliance and/or project quality.
Participate in internal and external audits if needed.

Education

Bachelor's or master's degree in computer science, Information Systems, QM or related field and/or related working experience.

Experience & Personal Attributes

10+ years of experience in CSV, QM, Test and Project Management, with at least 2 years in a leadership role.
Strong expertise in GxP requirements and guidelines like 21 CFR Part 11 regulations, GAMP 5 and Annex11 requirements for computerized systems.
Understanding, adapting and establishing GxP regulations, CSV and documentation best practices in regulated industries.
Strong Project- & Test management skills with the ability to adapt also solution-oriented compliance deliverables.
Familiar with several software development methodologies and the capability to adapt them for CSV.
Strong communication and stakeholder management skills, with the ability to build and maintain strong relationships across the organization and with external partners.
Capacity to face and adapt to challenges to overcome them (resilience).
Fluent English spoken and written, other languages are an asset (DE).

Work location

Straumann Group offices in Madrid/Wroclaw - Hybrid, with 2 remote working days/week.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Employment Type: Full Time

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