Vacancy QA Manager – Espergaerde


Organization

09 SEP ’22: An organisation with outstanding scientific and technological expertise is looking for a QA Manager. Helping to ensure the safety of millions of patients and healthcare practitioners around the world every year, this organisation is specialised in comprehensive sterilisation services for the medical device, pharmaceutical, food safety, and advanced applications markets. Their global network includes 48 facilities in 13 countries.

Function

As the new QA Manager, you will take an important role as part of the Danish management team, where you will be given the authority to represent the facility on all quality matters pertinent to the quality management system as established through customer and regulatory requirements. The QA Manager will act as a Qualified Person (QP) and together with the management group determine facility target plans and quality objectives to achieve business unit goals and targets.

Essential position duties include, but are not limited to:

  • Represent the company in quality matters;
  • People management and development of the QA Team;
  • Report to Corporate QA on the performance of the quality management system and any need for improvement;
  • Coordinate internal and external audits (a.o. customer, GMP, FDA, ISO);
  • Maintain contacts with supplier/customer (a.o. visits, meetings, complaint handling, audits).

Requirements

The ideal candidate is an experienced people leader within Quality Assurance. You have strong communication skills and have experience working in a structured manner to ensure the quality system continues to be suitable and effective in satisfying customer requirements, the requirements of Danish- and FDA regulatory requirements and in line with the quality policy and quality/facility targets.

Furthermore, as a suitable candidate, the following qualifications and experiences are expected:

  • Cand.Pharm. or a similar educational background;
  • Relevant experience in a management function;
  • Experience working with Modern Quality Systems & standards, GMP, FDA, and ISO;
  • Experience in the pharmaceutical and medical device industry is an advantage;
  • Experience in auditing;
  • Fluency in English (reading, speaking, writing).


Application

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


Miriam Peitersen
Principal Consultant | Nordics


+45 89 88 26 70
m.peitersen@qtcrecruitment.com