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.
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.
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.
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
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
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.
The QbD Group supports life science companies worldwide throughout the entire product lifecycle – from idea to patient. We are a global company with over 700 high-qualified employees.
Our experienced team serves the wider life science industry, with a strong focus on ATMPs, medical devices, IVDs, and digital health, thanks to the specific expertise we have built in these areas. The services we offer fall under the following divisions:
• Regulatory Affairs: We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle.
• Clinical: We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy.
• Qualification and Validation: We guarantee that products meet quality demands and comply with regulation through the qualification and validation of your processes, equipment, and software.
• Quality Assurance: We offer the full range of QA services necessary to get your product to market in a safe and compliant way, including auditing from certified auditors, setting up your QMS, and all QP (Qualified Person) activities.
• Quality Control: Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products.
• Software solutions: Cloud-based and pre-validated Quality Management Software built for the life sciences, as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions For Use (IFU).
• Go to market: We help you launch your product to market by providing marketing and communication services, business development support and sales strategy.
