QbD Group

• Your role covers the full quality lifecycle, from documentation and records management to audits, risk management, and continuous improvement. • Establish and maintain a controlled document and records management system, ensuring version control, traceability, and regulatory compliance. • Manage customer complaints and nonconforming services, including investigation, root cause analysis, corrective actions, and trend analysis. • Lead the CAPA process and ensure effective, structured root cause analysis using recognized methodologies. • Plan and conduct internal and supplier audits and act as the primary contact for inspections by regulators, certification bodies, clients, and partners. • Qualify and monitor suppliers, manage supplier performance, and oversee formal change control for quality-critical changes. • Define and monitor quality objectives and KPIs, reporting performance and driving continuous improvement in collaboration with global stakeholders. • Ensure validation and ongoing compliance of GxP-relevant and business-critical systems in cooperation with CSV specialists. • Lead risk assessments and coordinate management reviews, presenting quality performance, risks, and improvement actions. • Integrate quality considerations into business continuity planning and resilience testing. • Oversee compliant training programs, define competence requirements, and ensure ongoing evaluation and development of quality-critical roles. • Stay current with evolving regulations and industry standards, ensuring effective communication and proactive implementation of improvement.

• Oversee the planning and execution of all projects within the team, ensuring adherence to project governance processes • Support and guide Study Coordinators, enabling them to achieve success and deliver consistent results • Implement project management tools and templates across the team to increase operational efficiency • Continuously monitor project portfolios for risks, deviations, and resource utilization, driving actions for improvement • Lead the planning, execution, and delivery of critical strategic projects, ensuring timely and high-quality outcomes • Serve as the primary point of contact for clients and stakeholders, fostering strong relationships and effective communication • Identify risks, create mitigation plans, and ensure proactive issue resolution to keep projects on track • Develops and manages the study budget • Overall responsibility for negotiation of financial aspects of clinical performance studies/program • Interacts with senior internal management and external personnel on significant matters often requiring coordination between involved team members and stakeholders

• You’ll be the frontend owner of a live medical device SaaS platform used across Europe. • You’ll own the entire React frontend across multiple applications — a greenfield public-facing app built on Next.js 15 and Tailwind, and a battle-tested admin app that keeps the business running. • You’ll work alongside a backend developer and collaborate with a DevOps team and external customer teams. • The platform runs on AWS, serves customers across multiple countries, and is actively evolving.