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Straumann • Madrid, Community of Madrid, Spain
Role & seniority: CSV and Test Management Lead (senior, 10+ years in CSV/QM/Test/PM with at least 2 years in a leadership role)
Stack/tools: Enterprise Business Applications (SAP, S/4HANA, Salesforce, other enterprise apps), CSV governance, validation documentation, ALM/QA & Compliance coordination; GxP frameworks (21 CFR Part 11, GAMP 5, Annex 11)
Manage and review all validation documentation across SDLC with stakeholders (validation strategy, test plans, requirements, specs, traceability, risk analysis, validation reports)
Provide CSV guidance to project teams; drive and implement Test Management for business applications and major initiatives (e.g., S/4HANA) in line with ALM strategy
Align deliverables with QA/Compliance, coordinate global CSV/QA representatives, provide training, and participate in audits as needed
10+ years in CSV, QM, Test and Project Management; ≥2 years in a leadership role
Strong GxP expertise and familiarity with 21 CFR Part 11, GAMP 5, Annex 11
Proficient in project- and test-management; capable of adapting methodologies for CSV
Excellent communication and stakeholder management; ability to build cross-functional relationships
Fluent English (spoken/written); other languages are a plus (German)
Experience with SAP S/4HANA and integration across SAP/IT stakeholder groups
Prior exposure to regulated industries and global compliance programs
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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. As part of our digital transformation journey and business growth strategy, you will play a key role in contributing to major initiatives across the organization. You will report to the Head of Global Business Applications Processes, Toolchain, and Delivery. 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: Madrid, 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
Travel Percentage: 0 - 10%
Requisition ID: 20070