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 pharmaceuticalindustry.

• Proven experience with implementing and maintaining a QMScompliant 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-orientedmindset.

• 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.

📩 Interested? Let’s talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.

Originally posted on Himalayas