Quality Director

Our client is a premier international contract research organization that specializes in clinical trials in Central and Eastern Europe and CIS – the areas with the most compelling environment for biopharmaceutical research is looking for a Quality Director. Qualifications
  • a degree in life sciences, medical sciences, pharmaceutical field or similar and also in management;
  • at least 5 years of experience in the relevant field, 2-3 years of monitoring;
  • Previous relevant experience in Quality Assurance Manager or higher position within CRO/pharmaceutical company;
  • knowledge of ICH GCP and national regulations related to clinical trials;
  • excellent command of written and spoken English language;
  • excellent record retention, customer service, and interpersonal skills;
  • ability to work under time constraint; ability to establish and meet priorities, deadlines, and objectives;
Your tasks:
  • ensuring that all processes contributing to the performance of a clinical trial are conducted in accordance with ICH guidelines and other regulations;
  • implementing internal Quality review processes including developing and monitoring measurements of success;
  • coordinating activities of Quality Department and subordinate staff;
  • participating in reviewing and reporting findings and recommendations to senior management;
  • preparing Quality Audit Programs and leading the internal and external quality audit process;
  • providing Quality Assurance and Quality Control surveillance and support to projects to ensure adherence to quality plans;
  • managing the development of Total Quality Measurement system;
  • coordinating and assisting to cross-departments during the preparation of standard documents;
  • preparing standard documents relevant to scope of activities of Quality Department;
  • reviewing problems and procedures of departments and recommending solutions or changes in procedures;
  • controlling the status of the quality levels of staff, systems and production activities and participating in improvement programs;
  • participating in the evaluation of quality events, incidents and possible complaints and the follow-up activities;
  • obtaining client’s feedback;
  • keeping up to date with all related quality legislation and compliance issues;
  • representing the company during external audits/inspections and coordinating preparation process;
  • conducting management meetings to establish, delineate, and review organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures;
  • maintaining the internal audit system;
  • conducting internal system, process, documentary, on-site project audits and vendor audits;
  • preparing Audit Reports and CAPAs. Controlling of CAPA implementation for internal and external audits;
  • following all applicable requirements of Company’s standard documents and applicable legislation requirements.
We offer:
  • competitive salary and bonuses (to be discussed with the successful candidates);
  • an intelligent working environment in fast growing international company;
  • cheerful, friendly and enthusiastic team with positive attitude;
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