Quality Manager – Clinical

This is a fully remote position, open to applicants in Belgium.

📋 Description

• This position encompasses the entire quality lifecycle, including documentation and records management, audits, risk management, and ongoing improvement initiatives.

• Develop and maintain a controlled document and records management system, ensuring compliance with version control, traceability, and regulatory standards.

• Address customer complaints and nonconforming services through investigation, root cause analysis, corrective actions, and trend evaluation.

• Drive the CAPA process, ensuring effective and structured root cause analysis utilizing recognized methodologies.

• Organize and execute internal and supplier audits, serving as the main point of contact for inspections conducted by regulators, certification bodies, clients, and partners.

• Qualify and assess suppliers, oversee their performance, and manage formal change control for quality-critical alterations.

• Set and track quality objectives and KPIs, reporting on performance and fostering continuous improvement in collaboration with global stakeholders.

• Ensure the validation and ongoing compliance of GxP-relevant and business-critical systems in partnership with CSV specialists.

• Lead risk assessments and coordinate management reviews, presenting findings on quality performance, risks, and recommended improvement actions.

• Incorporate quality considerations into business continuity planning and resilience testing initiatives.

• Supervise compliant training programs, define competency requirements, and ensure continuous evaluation and development of roles critical to quality.

• Keep abreast of changing regulations and industry standards, ensuring effective communication and proactive implementation of improvements.

⛳️ Requirements

• Bachelor's or Master's degree in biological or (para-) medical sciences, Life Science, Quality Management, or equivalent experience.

• A minimum of 5 years of experience in a Quality Management role within the medical device or pharmaceutical industry.

• Demonstrated experience in implementing and maintaining a QMS compliant with GCP.

• Experience with both internal and external audits, including regulatory inspections.

• Extensive knowledge of GxP (primarily GCP), ISO 9001, ISO 13485, and applicable regulatory requirements relevant to the IVD, MD, Pharma, and Life Science sectors.

• Strong grasp of risk-based thinking and the integration of quality systems.

• Proficiency in QMS software systems and document control tools.

• Exceptional oral and written communication skills.

• Excellent interpersonal abilities, with skills in inspiration and motivation.

• Strong analytical and problem-solving competencies.

• High attention to detail and strong organizational capabilities.

• Demonstrates integrity and ethical conduct.

• Proactive and results-driven attitude.

• Capable of making timely and well-reasoned decisions.

• Ability to remain composed in challenging situations and sensitivity to cultural differences.

• Willingness to travel internationally.

• Fluent in English; proficiency in additional languages is a plus.

🏝️ Benefits

• 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 strive to provide the best possible environment for you to thrive in the life sciences field.

• 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.