Global Business Applications CSV and Test Management Lead

Straumann Group

León

Hybrid

EUR 90,000 - 130,000

Full time

14 days+

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Job summary

Straumann Group is seeking an experienced CSV and Test Management Lead to drive validated software solutions like SAP and Salesforce across Global Business Applications. The role focuses on delivering compliant validation and test management for major enterprise applications.

Ideal candidates bring over 10 years of CSV and project management experience, with at least 2 years in leadership, and strong knowledge of GxP and regulatory guidelines.

Qualifications

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, GAMP 5 and Annex11 for computerized systems.
Understanding and applying GxP regulations, CSV and documentation best practices in regulated industries.
Strong Project- & Test management skills with the ability to deliver compliance-focused deliverables.

Responsibilities

Manage and review validation documentation across SDLC in collaboration with Validation & Test Plans, User Requirements, Functional, Installation Specifications and Qualification Documents.
Provide CSV guidance to implementation or update project teams.
Improve CSV standards in alignment with IT and QA departments.
Define and drive Test Management for Business Applications and initiatives like S/4HANA in line with ALM Strategy.
Coordinate with Quality Assurance, Test Management and Compliance to align deliverables with CSV guidelines.
Coordinate local CSV and QA reps to meet global CSV compliance requirements.
Provide training and coaching on CSV standards and test approaches.
Collaborate with SAP and other business stakeholders to ensure compliance and project quality.
Participate in internal and external audits if needed.

Skills

CSV management

Test management

Leadership

Regulatory compliance

Stakeholder management

GxP knowledge

Quality Assurance

Communication

Education

Bachelor's or Master's in Computer Science / Information Systems or related field

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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