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 inte