Quality Assurance Manager - Geleen

Vacancy information

Publication date:March 10 2020
Employment type:Permanent
Sector:Biotechnical
Function Group:Quality/RA

Function Group: Quality/RA / QA Manager

Organization

For a biotech scale-up which is committed to develop regenerative therapeutic interventions, we are looking for a Quality Assurance Manager. They develop those regenerative therapeutic interventions to increase quality of life of the patients suffering neurodegenerative disorders, as of yet without therapeutic disease-modifying perspectives. They are convinced that the power of individual healing lies in the regenerative capacities of the patient’s own stem cells. Therefore they strive to become a global partner in cell therapy by developing, manufacturing and marketing safe and effective stem cell products which improve the quality of life, and prolong longevity in patients suffering debilitating neurodegenerative disorders, all over the world.

This organisation is a Dutch medical biotechnology company specialised in regenerative medicine, focused on bringing high qualified autologous stem cell products to the global market environment addressing short track programs (from bench to bedside). They own a dedicated, specialised GMP stem cell manufacturing laboratory in Geleen. They exist 6 years and have 18 employees now. Because of the growth and succes of the organisation we are looking for a QA Manager.

Function

The Quality Assurance Manager will be responsible for the maintenance and continuous improvement of the QMS and shall lead the quality department of an ATMP manufacturing company. The function shall responsibly manage the planning and execution of the daily quality assurance activities while ensuring compliance with international quality requirements as defined by the applicable guidelines and standards (FDA, EMA, EU GMP ATMP). The function will be a critical part of a dynamic internationally active biotech-company in the field of regenerative medicine.

Essential duties:

  • Efficiently manage and supervise the quality group, whilst monitoring and maintaining compliance with applicable GMP guidelines, authorisations and safety standards
  • Act as catalyst for change and improvement in performance and quality
  • Investigate and set standards for quality and health and safety
  • Ensure that manufacturing and control processes comply with standards on national and international level
  • Support the Qualified Person in his role

Efficiently manage and execute quality assurance activities including:

  • Working with operating staff to establish and improve procedures, standards and systems
  • Deviation and change activities (NC, CAPA, CC)
  • Quality document life cycle, records and label control (independent writing reviewing
  • and approving)
  • Reviews (batch records, quality records, PQR, MR)
  • Validation and qualification of processes, equipment, suppliers
  • Qualification, contract and performance management of suppliers
  • Determining training needs
  • Self-inspections and audits
  • Performance monitoring, statistical data analysis and trending

Requirements

What they hope to find in a candidate:

  • Master of Science in Pharmacy/Biotechnology or equivalent
  • More than 5-year knowledge of GMP (preferably experience with cellular products/ATMPs)
  • Fluent in English (verbal and written) and demonstrated writing skills
  • Sound knowledge of quality standards, methodologies and systems
  • Proven ability to effectively participate in multi-disciplinary and multi-culture teams
  • Good understanding of European regulation (ATMP)
  • Willing to assist in manufacturing of the cell product at international sites (mostly related to the clinical trials)
  • Accurate, proactive, self-organised, flexible, attention to detail, team player

Offer

The organisation can offer a candidate a salary between €55,000 and €65,000 depending on the experience combined with competitive secondary benefits.

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Stijn Koehler
Sr Consultant Biotech/Pharma

+31(0)6-82400785
+31(0)23-7548660
s.koehler@qtcrecruitment.com

Apply

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