Senior Quality Assurance Expert

2 months ago

Herlev, Herlev Kommune, Denmark Nordic Bioscience Full time
Drive Excellence in Quality Assurance

Nordic Bioscience, a pioneering research-driven company, is seeking an exceptional Senior Quality Assurance Expert to join our dynamic QA team.

About the Role

This diverse and challenging role involves providing expert support to the QA team and cross-functional project groups on industry standards and regulations, including GMP, GCP, GCLP, CAP, CLIA, ISO9001, ISO13485, ISO15189, and FDA 21 CFR part 11. You will also collaborate with colleagues to rotate through various roles during inspections from clients and authorities, acting as a QA subject matter expert and audit host.

Key responsibilities include leading investigations into quality-related issues, performing root cause analysis, and implementing corrective and preventive actions. You will identify opportunities for process improvement through internal audits and contribute to the enhancement of quality assurance practices with a focus on simplicity in all processes.

About the Ideal Candidate

We are looking for a driven individual passionate about continuous improvement of quality processes through close collaboration with stakeholders from other departments. You should possess a deep understanding of GxP and industry standards, with a strong desire to advance and become a leading QA specialist.

  • Experience from QA roles within the pharmaceutical or biotech industry is essential.
  • A strong understanding of quality management systems and regulatory requirements, along with excellent communication skills, is required.
  • You must thrive in a dynamic environment, be adaptable to changing tasks and project teams, and express yourself clearly and precisely in English for both internal and external communication.
About Nordic Bioscience

Nordic Bioscience specializes in the development of biomarkers for diagnostics and prognosis of various chronic diseases. Our laboratory conducts analyses of clinical samples for external partners, including CROs and Pharma/Biotech companies.

We prioritize upholding the highest standards of quality, and your role will play a crucial part in maintaining our commitment to excellence and dedication to our clients. As a Senior Quality Assurance Expert, you will work closely with our QA Manager and colleagues to drive quality assurance excellence throughout the organization.

Compensation

The estimated annual salary for this position is approximately €80,000 - €110,000, depending on experience and qualifications. This figure may vary based on individual circumstances.

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