# Quality Manager Clinical **Company:** QbD Group **Department:** Quality Assurance **Remote status:** Fully Remote ## 🔍 _Quality Manager Clinical_ đź“Ť **Location** : _Remote - Europe_ đź•“ **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. ## đź’ˇ 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. ## đź’Ş 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 software systems** and document control tools. - Excellent oral and written communications skills - Excellent interpersonal skills, inspirational and motivational skills - Analytical and problem-solving skills. - **Attention to detail** and organizational skills. - Demonstrates integrity and ethical conduct. - **Proactive and results-oriented** mindset. - Demonstrates **ability to make timely and well-reasoned decisions** - Ability to maintain composure in difficult circumstances and sensitive to cultural differences - Open to **international travel** - Fluent in **English**. Other languages are a plus ## 🫵 Who you are Our culture is driven by values If this sounds like you, you’ll fit right in: - You’re **resilient** and tackle challenges with a positive mindset - You’re **curious** and always up for learning something new - You have a **no non-sense approach** honest, clear, respectful - You’re **innovative** and bring ideas, not just opinions - And above all, you’re **serious about your work, but not too serious about yourself** ## ✨ About us We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma. We believe in **JPEG** : **Joy. Partnership. Going the Extra Mile. Getting Things Done.** You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger. đź“© **Interested? Let’s talk.** Send us your CV and motivation letter. You could be the next one to join the QbD family. _This position is no longer accepting applications._