Quality Manager – Clinical

Job Description

This position is responsible for the entire quality lifecycle, encompassing documentation and records management, audits, risk management, and continuous improvement. The role involves establishing and maintaining a controlled document and records management system, ensuring version control, traceability, and regulatory compliance. Managing customer complaints and nonconforming services, including investigation, root cause analysis, corrective actions, and trend analysis is required. Leading the CAPA process and ensuring effective, structured root cause analysis using recognized methodologies is also essential. Planning and conducting internal and supplier audits, acting as the primary contact for inspections by regulators, certification bodies, clients, and partners is a key responsibility. Supplier qualification and monitoring, managing supplier performance, and overseeing formal change control for quality-critical changes is necessary. Defining and monitoring quality objectives and KPIs, reporting performance, and driving continuous improvement in collaboration with global stakeholders is required. Ensuring validation and ongoing compliance of GxP-relevant and business-critical systems in cooperation with CSV specialists is a must. Leading risk assessments and coordinating management reviews, presenting quality performance, risks, and improvement actions is also required. Integrating quality considerations into business continuity planning and resilience testing is essential. The role also involves overseeing compliant training programs, defining competence requirements, and ensuring ongoing evaluation and development of quality-critical roles. Staying current with evolving regulations and industry standards, ensuring effective communication and proactive implementation of improvement is crucial.

Qualifications

1. Bachelor or Master degree in biological or (para-) medical sciences, Life Science, Quality Management or equivalent by experience. 2. Minimum 5 years of experience in a Quality Management role within the medical device, or pharmaceutical industry. 3. Proven experience with implementing and maintaining a QMS compliant with GCP. 4. Experience with internal and external audits, including regulatory inspections. 5. Deep knowledge of GxP (mainly GCP), ISO 9001, ISO 13485 and applicable regulatory requirements applicable with the IVD, MD, Pharma and LifeScience industries. 6. Strong understanding of risk-based thinking and quality system integration. 7. Proficiency in QMS software systems and document control tools. 8. Excellent oral and written communications skills. 9. Excellent interpersonal skills, inspirational and motivational skills. 10. Analytical and problem-solving skills. 11. Attention to detail and organizational skills. 12. Demonstrates integrity and ethical conduct. 13. Proactive and results-oriented mindset. 14. Demonstrates ability to make timely and well-reasoned decisions. 15. Ability to maintain composure in difficult circumstances and sensitive to cultural differences. 16. Open to international travel. 17. Fluent in English. 18. Other languages are a plus.

Benefits

- Make a real impact: Be instrumental in shaping the future of the Life Sciences industry by aiding 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: Work in an ambitious and pioneering company, that offers the best possible environment to thrive within the life sciences. - A fair, competitive package: Get tailored, transparent compensation aligned with your expertise, preferences, and local market regulations.