Vacancy Director Quality Management – Zeist


Organization

14 NOV ’22: For Julius Clinical, a young and strongly growing organisation in the Clinical Trial field, we are looking for an experienced Director Quality Management. The organisation distinguishes itself by combining operational excellence with the latest scientific insights to develop innovative solutions, enabling clients to bring their treatments to the market faster.

Function

As the Director QM, you will be the key to defining Julius Clinical its Quality Management strategy. This role is on oversight in which you will spearhead 3 departments: General Compliance & Training, Project Compliance and QA.

Together with the COO, the Director QM will ensure solid organisation-wide support for QA, resulting in maintaining the high-quality standards of Julius Clinical. Moreover, the role focuses on:

  • Managing the internal CAPA program;
  • Ensuring new technologies and methods are implemented in the QMS;
  • Facilitating the creation of quality risk assessments;
  • Line management for the QA and General Compliance departments;
  • Maintaining ongoing consultation between all departments to improve quality and advise in resolving quality issues;
  • Complying with and monitoring department budgets;
  • Providing input to Business Development in clinical trial proposals.

Requirements

As a QA professional with a solid foundation and proven work experience under GCP you bring along at least ten years of experience in the pharmaceutical/CRO industry and at least eight years of QA work experience. The right fit candidate for this opportunity can prioritise work, on the oversight level. Furthermore, you bring along:

  • A higher level of education ((bio)medical field is a pré);
  • A minimum of five years’ international auditing experience (including vendors/sites);
  • Extensive knowledge in GxP (focus on GCP) and legislation/regulations related to quality management and clinical research;
  • The ability to proficiently communicate and interact with management at partners/sponsors;
  • Experience in line management with the ability to achieve development;
  • Experience with regulatory inspections from a hosting perspective;
  • Profound competence to communicate in the English language.

Offer

Besides being part of an organisation that has proven to be a favourable partner to its clients, you will be a crucial component to professionalising further and growing (with) the organisation to achieve its objectives. Moreover, the role allows a certain degree of freedom in work and flexibility in practical aspects. The package for this position is:

  • A competitive base salary, tailored to experience;
  • ABP pension (70% employer / 30% employee);
  • A bonus arrangement;
  • 30 holidays;
  • Daily homework allowance;
  • Work-from-home budget of EUR 600.

Application

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

Sander Westerhout
Associate | Biotechnology

+31 6 51 66 69 96
+31 23 754 86 60
s.westerhout@qtcrecruitment.com