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 Groups 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.

Whats 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 youll 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 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 youll fit right in:

• Youre resilient and tackle challenges with a positive mindset

• Youre curious and always up for learning something new

• You have a no non-sense approach honest clear respectful

• Youre innovative and bring ideas not just opinions

• And above all youre 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 wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.

Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.