Jobs at QbD Group

Own and develop the backend of a regulated medical device SaaS platform, including APIs, data layers, integrations, architecture, testing, and code quality. Work with Java, Kotlin, Spring Boot, MySQL, AWS, Docker, and Jenkins while making architectural decisions and maintaining legacy code. Collaborate remotely with frontend, backend, DevOps, and customer teams, using AI coding tools responsibly. Strong English and backend experience in SaaS are required; regulated-industry experience is beneficial.

Provide first-line B2B customer support and guide clients through implementation of e-labeling software. Advise on quality systems, regulatory compliance, security, vendor management and validation. Collaborate with cross-functional stakeholders, analyze client information, contribute to service improvements, and support client success while developing into technical or project roles.

Provide QA oversight for equipment, automation, processes, and computerized-system validation in GMP-regulated life sciences environments. Review and approve validation documentation, risk assessments, technical changes, and qualification activities. Support CSV, data integrity, device and combination-product activities, FMEA, change control, and quality risk management while advising engineering, manufacturing, product development, and information systems teams.

Own end-to-end recruitment for Life Sciences roles across the Netherlands and Belgium. Source senior talent, build freelance specialist networks and pipelines, advise business leaders on hiring needs, manage stakeholder relationships, support employer branding, and analyze recruitment funnel performance. The role is based 80% onsite in Breda with weekly travel to Antwerp and requires strong Dutch and English communication skills.

Supports HR and recruitment activities in Barcelona, including profile definition, job posting, CV screening, candidate interviews, international sourcing, vacancy database management, onboarding, employee training coordination, and HR quality processes. The role requires a relevant degree, strong English proficiency, organization, autonomy, enthusiasm, and eligibility to sign a university agreement.

Lead European regulatory submissions, renewals, variations, lifecycle management, and regulatory strategy for medicinal products. Coordinate eCTD publishing, electronic submissions, product information maintenance, health authority interactions, and responses to regulatory queries. Assess regulatory impacts of business and manufacturing changes, ensure compliance with EU pharmaceutical requirements, manage multiple priorities, and mentor junior team members.

Provide hands-on GMP quality assurance support across pharma/biotech/MedTech projects: batch review and release, deviations/CAPAs, change controls, sterile manufacturing exposure, audit/inspection support, and stakeholder communication while progressing toward QP responsibilities.

Lead strategic business development for MedTech (Medical Device/IVD) clients across Europe. Build and manage long-term client relationships, identify commercial opportunities from regulatory trends, run consultative sales with senior stakeholders, maintain accurate CRM pipeline, win mid-size and large accounts, represent the company at industry events, and collaborate with consultants and internal teams to deliver solutions.

Ensure robust Quality Management Systems in GMP-regulated environments. Support CAPAs, deviations, change controls, complaints, and quality events. Perform QA batch record review and support material/batch release. Ensure GMP/regulatory compliance, contribute to audits and inspection readiness, collaborate with stakeholders to drive continuous quality improvements and optimize quality systems.

Lead and grow the Toxicology Business Unit: deliver toxicology consulting projects, ensure scientific and regulatory quality, manage operations, support proposals and client engagement, and help shape the service portfolio and market positioning.

Lead planning, execution, and governance of clinical performance studies for IVD devices. Manage high-value projects and the project portfolio, support study coordinators, implement PM tools and templates, own budgets and financial negotiations, drive risk mitigation, stakeholder communication, and continuous improvement across cross-functional, global teams.

Support clients to achieve Annex 1 sterile manufacturing compliance by providing hands-on expertise in isolators, RABS, cleanroom design and qualification, aseptic techniques, process validation, contamination control (CSS plans), and environmental monitoring programs.

Perform on-site and remote GxP/ISO 13485/MDR/IVDR audits worldwide, produce and follow up audit reports, provide corrective recommendations, support clients in remediation, and maintain up-to-date regulatory knowledge.

Certified Qualified Person (QP) to support GMP-regulated pharma and biotech projects. Duties include batch certification and release, GMP oversight, reviewing deviations/CAPAs/change controls, audit and inspection support, sterile manufacturing oversight, stakeholder collaboration, and driving quality system improvements across clients.

Lead and coordinate clinical trials ensuring subject safety, protocol and regulatory compliance (GCP/ISO). Oversee data quality, study documentation, budgets, vendor management, recruitment/retention, timelines, and stakeholder communication.

Lead business development across China for life sciences clients (Medical Device/IVD, Pharma/Biotech). Identify prospects, build networks and partnerships, create proposals and maintain a sales pipeline, collaborate with internal experts and marketing, and localize materials for the Chinese market to drive strategic, long-term engagements.

Perform QA activities in a GMP life‑sciences environment: maintain quality records, perform risk assessments, investigate deviations and CAPAs, review batch records and support batch release, support audits/inspections, and collaborate cross‑functionally to ensure compliance and product quality throughout development and production.