Quality Manager Clinical

🔍 Quality Manager Clinical 📍 Location : Remote - Europe 🕓 Type : Full-time The Quality Manager is responsible for the development, implementation, maintenance, and continuous improvement of QbD Group ’s Quality Management System (QMS), ensuring its alignment with applicable international standards – such as GCP, ISO 9001, ISO 13485 and other GxP regulations - as well as relevant local and international legal and regulatory requirements. A role focused on internal QA within the Clinical area , with direct collaboration with the Head of iQA and the Global Head of the Clinical Division. 💡 What’s in it for you? Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise. Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences. A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued. 🏢 What you’ll be doing Your role covers the full quality lifecycle, from documentation and records management to audits, risk management, and continuous improvement. - Document & Record Management: Establish and maintain a controlled document and records management system, ensuring version control, traceability, and regulatory compliance. - Complaint Handling & Nonconformities: Manage customer complaints and nonconforming services, including investigation, root cause analysis, corrective actions, and trend analysis. - CAPA & Root Cause Analysis: Lead the CAPA process and ensure effective, structured root cause analysis using recognized methodologies. - Audits & Inspections: Plan and conduct internal and supplier audits and act as the primary contact for inspections by regulators, certification bodies, clients, and partners. - Supplier & Change Management: Qualify and monitor suppliers, manage supplier performance, and oversee formal change control for quality-critical changes. - Quality Objectives & KPIs: Define and monitor quality objectives and KPIs, reporting performance and driving continuous improvement in collaboration with global stakeholders. - Software Validation: Ensure validation and ongoing compliance of GxP-relevant and business-critical systems in cooperation with CSV specialists. - Risk Management & Management Review: Lead risk assessments and coordinate management reviews, presenting quality performance, risks, and improvement actions. - Business Continuity: Integrate quality considerations into business continuity planning and resilience testing. - Training & Competence Management: Oversee compliant training programs, define competence requirements, and ensure ongoing evaluation and development of quality-critical roles. - Continuous Improvement & Compliance: Stay current with evolving regulations and industry standards, ensuring effective communication and proactive implementation of improvement. 💪 What you bring - Bachelor or Master degree in biological or (para-) medical sciences, Life Science, Quality Management or equivalent by experience - Minimum 5 years of experience in a Quality Management role within the medical device, or pharmaceutical industry . - Proven experience with implementing and maintaining a QMS compliant with GCP. - Experience with internal and external audits , including regulatory inspections. - Deep knowledge of GxP (mainly GCP), ISO 9001, ISO 13485 and applicable regulatory requirements applicable with the IVD, MD, Pharma and LifeScience industries. - Strong understanding of risk-based thinking and quality system integration - Proficiency in QMS soft