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Head of quality assurance


The ISO E 8402:1994 Standard of the International Organisation for Standardisation defines quality as "the totality of features and characteristics of a product or service that have a bearing on its ability to satisfy stated or implied needs". Some of the quality systems most commonly-used in the field of the biotechnology and biomedicine are the ISO quality regulations focused on the processes, Good Practices regulations (GLP/GMP/GCP) and the CE Mark for the certification of medical devices.

The objective of these regulations is to ensure that what is carried out complies with requirements previously set forth by law and by the company's objectives, that it can be reproduced, is traceable, correctly documented and that the staff is perfectly qualified to carry out the assigned tasks. For this reason, companies establish a quality management system that has the double function of quality assurance and control. These functions are often the responsibility of a specific department that reports directly to general management or can be outsourced to a specialised consultancy.

The person responsible for quality in biotechnology works in two areas: quality guarantee (define the framework and reference standards) and quality control (define the processes, internal verification systems and application of corrective actions). They must define the quality assurance strategy, the types of regulations which must be fulfilled, the allocated resources and the necessary checks on technical teams and staff.


  • Together with the company's management team, define the quality assurance strategy and the types of regulations to be observed, in addition to those which are compulsory based on the type of activity.
  • Describe the training the staff needs to carry out the activity in accordance with the regulations and ensure that the descriptions of the jobs are consistent with the assigned responsibilities.
  • Define which audits are carried out with external suppliers and which ones are carried out internally.
  • Define the necessary quality tests and control points of the processes.
  • Define the communication channels for quality problems and the establishment of corrective actions.
  • Establish a Standardised Operating Procedures (SOP) system that ensures the quality of the suppliers, technical equipment, staff training and end product.
  • Review and sign the internal audit reports.
  • Stay in contact with the public institutions that perform the audits or the notifying entities in order to attend to the external audits of the competent body or other companies.
  • Stay in contact with the certification organisations in order to obtain and keep in force the official stamp of the regulations that is requested (ISO, BPL).
  • Review and support the technical management teams, together with those responsible for regulatory matters, so that the studies' design and the documentation on safety (pre-clinical and clinical) and manufacturing comply with the current regulations and the clinical trials or product registration can be carried out.
  • Stay up-to-date on the drafts and new regulations of the regulatory agencies, like the FDA (Food & Drug Administration in the United States) and the EMA (European Medicines Agency in the EU).

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