Quality Manager – Clinical

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

📋 Description

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

• Develop and uphold a controlled document and records management system that guarantees version control, traceability, and adherence to regulations.

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

• Spearhead the CAPA process and ensure thorough root cause analysis using established methodologies.

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

• Assess and monitor suppliers, manage supplier performance, and oversee formal change control for quality-critical modifications.

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

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

• Lead risk assessments and coordinate management reviews, presenting quality performance, risks, and areas for improvement.

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

• Supervise compliant training programs, establish competence requirements, and ensure the continuous evaluation and development of quality-critical roles.

• 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.

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

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

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

• Comprehensive knowledge of GxP (especially GCP), ISO 9001, ISO 13485, and relevant regulatory requirements pertaining to the IVD, MD, Pharma, and LifeScience sectors.

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

• Proficient in QMS software systems and document control tools.

• Exceptional oral and written communication abilities.

• Strong interpersonal skills, with the capability to inspire and motivate others.

• Analytical and problem-solving abilities.

• Keen attention to detail and exceptional organizational skills.

• Exhibits integrity and ethical behavior.

• Possesses a proactive and results-driven attitude.

• Shows capacity for timely and well-reasoned decision-making.

• Capable of maintaining composure in challenging situations and sensitive to cultural differences.

• Willingness to travel internationally.

• Fluent in English; additional languages are advantageous.

🏝️ 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 expand your expertise.

• Build a meaningful career: As an ambitious and pioneering company, we aim to provide the best possible environment for you to thrive in the life sciences.

• A fair, competitive package: We offer customized, transparent compensation that aligns with your expertise, preferences, and local market regulations — because your contributions deserve recognition.