Global Business Applications CSV and Test Management Lead

Straumann Group; Granada; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Straumann Group is seeking an experienced CSV and Test Management Lead to drive validation across SAP and other enterprise applications in Madrid with hybrid work arrangements. The role requires leading CSV strategy, ensuring compliance with 21 CFR Part 11 and GAMP 5, coordinating with IT, QA, and external auditors, and coaching teams on best practices.

Fluency in English is required, with additional languages a plus.

Qualifications

• 10+ years of CSV, QM, Test and PM experience with leadership exposure.
• Strong GxP knowledge and 21 CFR Part 11, GAMP 5, Annex11.
• Experience with SAP and enterprise applications in regulated industries.

Responsibilities

• Manage validation documentation across SDLC with stakeholders.
• Provide CSV guidance to implementation project teams.
• Improve CSV standards in line with IT and QA requirements.
• Define, drive and implement Test Management for Business Applications incl. S/4HANA.
• Coordinate with QA, Compliance and validation teams for alignment.
• Support audits and provide training on CSV standards.

Skills

CSV Expertise

Test Management

Regulatory Compliance

Project Management

Stakeholder Mgmt

SAP

GxP knowledge

English fluency

Education

Bachelor's or Master's in Computer Science or related

Tools

S/4HANA

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.

Requirements 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

Alternative Locations

Spain : Madrid || Brazil : Curitiba || Poland : Gdansk || Poland : Wroclaw || Spain : Albacete || Spain : Alcobendas || Spain : Alicante || Spain : Almería || Spain : Araba || Spain : Asturias || Spain : Badajoz || Spain : Barcelona || Spain : Bilbao || Spain : Burgos || Spain : Cantabria || Spain : Castelló || Spain : Ciudad Real || Spain : Cuenca || Spain : Cáceres || Spain : Cádiz || Spain : Córdoba || Spain : Gipuzkoa || Spain : Girona || Spain : Granada || Spain : Guadalajara || Spain : Huelva || Spain : Huesca || Spain : Illes Balears || Spain : Jaén || Spain : La Coruña || Spain : La Rioja || Spain : Las Palmas || Spain : León || Spain : Lleida || Spain : Lugo || Spain : Mendaro || Spain : Murcia || Spain : Málaga || Spain : Navarra || Spain : Ourense || Spain : Palencia || Spain : Pontevedra || Spain : Salamanca || Spain : Santa Cruz de Tenerife || Spain : Segovia || Spain : Sevilla || Spain : Soria || Spain : Tarragona || Spain : Teruel || Spain : Toledo || Spain : Valencia || Spain : Valladolid || Spain : Zamora || Spain : Zaragoza || Spain : Ávila

Travel Percentage

0 - 10%

Requisition ID

20070

20070