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Quality Manager Clinical

April 25, 2026

<h2>🔍 Quality Manager Clinical</h2>📍 Location: Remote - Europe 🕓 Type: Full-timeThe 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.<h2>💡 What’s in it for you?</h2>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 devicesGrow 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. <h2>🏢 What you’ll be doing</h2>Your role covers the full quality lifecycle, from documentation and records management to audits, risk management, and continuous improvement.<ul><li class="MsoNormal">Document & Record Management: Establish and maintain a controlled document and records management system, ensuring version control, traceability, and regulatory compliance.</li><li class="MsoNormal">Complaint Handling & Nonconformities: Manage customer complaints and nonconforming services, including investigation, root cause analysis, corrective actions, and trend analysis.</li><li class="MsoNormal">CAPA & Root Cause Analysis: Lead the CAPA process and ensure effective, structured root cause analysis using recognized methodologies.</li><li class="MsoNormal">Audits & Inspections: Plan and conduct internal and supplier audits and act as the primary contact for inspections by regulators, certification bodies, clients, and partners.</li><li class="MsoNormal">Supplier & Change Management: Qualify and monitor suppliers, manage supplier performance, and oversee formal change control for quality-critical changes.</li><li class="MsoNormal">Quality Objectives & KPIs: Define and monitor quality objectives and KPIs, reporting performance and driving continuous improvement in collaboration with global stakeholders.</li><li class="MsoNormal">Software Validation: Ensure validation and ongoing compliance of GxP-relevant and business-critical systems in cooperation with CSV specialists.</li><li class="MsoNormal">Risk Management & Management Review: Lead risk assessments and coordinate management reviews, presenting quality performance, risks, and improvement actions.</li><li class="MsoNormal">Business Continuity: Integrate quality considerations into business continuity planning and resilience testing.</li><li class="MsoNormal">Training & Competence Management: Oversee compliant training programs, define competence requirements, and ensure ongoing evaluation and development of quality-critical roles.</li><li class="MsoNormal">Continuous Improvement & Compliance: Stay current with evolving regulations and industry standards, ensuring effective communication and proactive implementation of improvement.</li></ul><h2>💪 What you bring</h2><ul><li class="MsoNormal">Bachelor or Master degree in biological or (para-) medical sciences, Life Science, Quality Management or equivalent by experience</li><li class="MsoNormal">Minimum 5 years of experience in a Quality Management role within the medical device, or pharmaceutical industry.</li><li class="MsoNormal">Proven experience with implementing and maintaining a QMS compliant with GCP.</li><li class="MsoNormal">Experience with internal and external audits, including regulatory inspections.</li><li class="MsoNormal">Deep knowledge of GxP (mainly GCP), ISO 9001, ISO 13485 and applicable regulatory requirements applicable with the IVD, MD, Pharma and LifeScience industries.</li><li class="MsoNormal">Strong understanding of risk-based thinking and quality system integration</li><li class="MsoNormal">Proficiency in QMS software systems and document control tools.</li><li class="MsoNormal">Excellent oral and written communications skills</li><li class="MsoNormal">Excellent interpersonal skills, inspirational and motivational skills</li><li class="MsoNormal">Analytical and problem-solving skills.</li><li class="MsoNormal">Attention to detail and organizational skills.</li><li class="MsoNormal">Demonstrates integrity and ethical conduct.</li><li class="MsoNormal">Proactive and results-oriented mindset.</li><li class="MsoNormal">Demonstrates ability to make timely and well-reasoned decisions</li><li class="MsoNormal">Ability to maintain composure in difficult circumstances and sensitive to cultural differences</li><li class="MsoNormal">Open to international travel</li><li class="MsoNormal">Fluent in English. Other languages are a plus</li></ul><h2>🫵 Who you are</h2>Our culture is driven by values If this sounds like you, you’ll fit right in:<ul><li>You’re resilient and tackle challenges with a positive mindset</li><li>You’re curious and always up for learning something new</li><li>You have a no non-sense approach honest, clear, respectful</li><li>You’re innovative and bring ideas, not just opinions</li><li>And above all, you’re serious about your work, but not too serious about yourself</li></ul><h2>✨ About us</h2>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.📩 Interested? Let’s talk. Send us your CV and motivation letter. You could be the next one to join the QbD family.

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...