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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Quality Assurance and Quality Engineering within regulated environments, particularly in Life Sciences, Pharma, or Medical Devices. Proficient in managing testing processes, leading teams, and ensuring compliance with GxP and Computer System Validation standards.
Highest-signal resume keywords
Quality Assurance LeadershipGxP ComplianceSAP Solution Manager ExpertiseTesting Frameworks for ERP SystemsStakeholder Engagement and Conflict Resolution
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Assurance MethodologyTest Workflow DesignTest Phase ManagementDefect Metrics MonitoringRisk AssessmentContinuous Improvement StrategiesTesting DocumentationSOP AuthoringUser Guide DevelopmentQuality Audit Management
Soft Skills
Exceptional CommunicationNegotiation SkillsMatrix ManagementTeam MentoringInfluencing Senior Executives
Tools & Technologies
SAP Solution ManagerJiraAzure DevOpsMicro Focus ALMQuality Center
Industry Keywords
Computer System ValidationRegulated EnvironmentsLife SciencesPharmaMedical DevicesFDA ComplianceEMA ComplianceERP ImplementationTesting FrameworksQuality Standards
Tech Stack
Tools & technologiesAzureERP
About the role
Key responsibilities & impact- Own the master version of the ASPIRE Test Methodology
- Identify operational gaps, friction points, and missing controls in the ASPIRE lifecycle
- Design, pilot, and deploy testing workflows, templates, and frameworks
- Ensure process updates are pre-validated with CSV and Quality teams
- Author SOPs, Work Instructions, User Guides, and Test Summary Reports
- Lead quality assurance and quality engineering for complex, strategic ERP projects
- Ensure consistency, test traceability, and alignment with enterprise standards
- Manage test phases including SAT, UAT, and RT against the global release calendar
- Monitor testing metrics, defect burn-down rates, and resource allocation
- Present quality verdicts and go-live readiness to stakeholders
- Act as lead testing subject matter expert during internal and external quality audits
- Maintain robust testing documentation and traceability
- Manage deviations from the ASPIRE methodology through risk assessment and documentation
- Advise project teams on complex testing requirements
- Direct and mentor a small support team assisting with reporting and SolMan updates
- Manage stakeholder engagement, resolve conflicts, and build consensus on quality standards and release criteria
- Guide strategic solution evaluation, risk assessment, transitions, and future states
- Embed best practices, coach peers, and foster continuous improvement
Requirements
What you’ll need- Extensive experience providing expert-level leadership and strategic guidance for high-impact software quality assurance projects
- Proven track record of managing teams of quality engineers, establishing quality standards, and driving continuous improvement in testing strategies
- Extensive experience working within regulated environments (Life Sciences, Pharma, or Medical Devices)
- Deep operational knowledge of GxP and Computer System Validation (CSV)
- Proven track record of managing and defending testing processes during internal corporate quality audits and external regulatory inspections (e.g., FDA, EMA)
- Expertise in recommending quality assurance technologies and tools for business transformation
- Advanced systems thinking and analytical reasoning to identify systemic quality issues, future risks, and strategic improvement opportunities
- Deep technical expertise in SAP Solution Manager (SolMan), SAP Focused Build, or modern ALM tools (e.g., Jira, Azure DevOps, Micro Focus ALM/Quality Center)
- Experience in ERP implementation programs/projects
- Comprehensive understanding of testing frameworks and tools suited for enterprise ERP systems
- Ability to navigate complex stakeholder networks, manage conflicts, and drive executive consensus
- Exceptional communication, negotiation, and matrix-management skills
- Ability to influence senior executives and challenge project deployment timelines when quality is at risk
Benefits
Comp & perks- Annual bonus payment based on your performance
- Dedicated training budget (training, certifications, conferences, diversified career paths etc.)
- Recharge Fridays (2 Fridays off per quarter available)
- Take time Program (up to 3 months of leave to use for any purpose)
- Vacation subsidy available
- Flex Location (possibility to perform our work from different places in the world for a certain period of time)
- Take Time for Charity (additional paid leave of maximum 2 weeks to engage in the charity action of your choice)
- Private healthcare (LuxMed packages)
- Group life insurance (UNUM)
- Multisport
- Stock share purchase additions
- Yearly sales of company laptops and cars
- Attractive benefits package
- Discretionary annual bonus with a target of 20% subject to individual and company performance