Manager Quality Assurance
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Job Location:
Leiden - Netherlands
Monthly Salary:
Not Disclosed
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
Job description
We are seeking an experienced Manager Quality Assurance (QA) to lead a small team of skilled QA professionals and maintain the Quality Management System ensuring compliance with the applicable quality standards. The ideal candidate has several years of experience in a comparable QA leadership role strong knowledge of ISO and GCLP requirements and is available for 32-40 hours per week.
Who are we
GenomeScan is an ISOaccredited leader in Next Generation Sequencing services providing stateoftheart tools for fast affordable and highquality patient diagnosticscrucial for identifying disease causes and supporting personalized treatment plans. GenomeScan drives innovation through close partnerships with medical centres and research laboratories.
We take on a diverse range of challenging projects using advanced Next Generation Sequencing (NGS) techniques including Whole Genome and Gene-panel Sequencing RNA- and Methyl sequencing and various bioinformatics pipelines. Our laboratory is equipped with Illumina Ion Torrent and Nanopore sequencers as well as robotic systems for automated sample processing. GenomeScan complies with international quality standards and holds ISO/IEC 17025 accreditation.
In addition to our current ISO accreditation we are implementing GCLP guidelines in our laboratory to improve and expand our services for clinical trials.
What will you do
You will:
Be responsible for maintaining a Quality Management System (QMS) that ensures compliance with GCLP ISO/IEC 17025 and ISO 15189 quality standards.
Monitor and evaluate QA procedures.
To manage the QA team and monitor motivate and stimulate the development well-being and performance of direct reporting staff.
Keep the Quality Manual updated.
Organize periodic QA meetings to identify and discuss operational quality problems and identify areas for improvement.
Manage effective action plans in response to complaints deviations and audit findings.
Manage internal and external audits.
Organize participation in relevant proficiency tests and/or ring trials.
Verify if Standard Operating Procedures (SOPs) and equipment documentation are in place complete and up to date together with responsible staff.
Promote and communicate quality and stimulate continuous improvement of the QMS throughout the organization.
Report to the Board on the functioning and effectiveness of the QMS.
Represent the organization on quality issues in relevant internal and external meetings.
What do we offer you
Meaningful work with a challenging role at a company that believes Next Generation Sequencing applications contribute to improving healthcare.
A competitive salary based on your knowledge and experience.
An end-of-year bonus/ 13th month payment (8.3% of gross annual salary).
A holiday allowance (8% of gross annual salary).
A total of 200 holiday hours (based on full-time employment for a full year) with the possibility of buying/selling leave hours.
A collective pension scheme with 50% of the contribution paid by GenomeScan (Partner pension is included).
A travel allowance or NS Business Card for your commute to and from Leiden.
Job requirements
What do we ask for
Bachelors degree in Life Sciences or Molecular Biology or equivalent educational level.
A minimum of 5 years of experience in quality management within Life Sciences.
Strong knowledge of relevant guidelines such as ISO/IEC 17025 ISO 15189 GCLP and preferably NEN7510/7512.
A minimum of 3 years of experience in a comparable QA leadership role.
Experience with managing digital Quality Management Systems.
Experience with performing audits.
Excellent knowledge of Dutch and English both in word and writing.
Willing and able to work on-site (Leiden) when the work requires.
Do you see yourself in this role Great! We look forward to receiving your application!
Not sure yet Would you like to know more first Contact Yvonne Klein at .
- Leiden Netherlands
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Required Experience:
Manager
