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(Sr.) Manager CQA Leiden Netherlands,  

Posted on : 19 June 2017

Project Description

Do you have a Bachelors degree and would you like to become a Quality Assurance expert? Would you like to have a versatile position in a growing team? Then Astellas has an interesting job opportunity for you!                                               (Senior) Manager Clinical QA (Fixed term for 1 year) Fulltime, 40 hours, Leiden, The Netherlands   Your job as (Senior) Manager Clinical QA As a (Senior) Manager Clinical QA you are responsible for the development and maintenance of excellence in Clinical QA activities for Astellas sponsored programs. In this position you work in partnership with Medical and Development (M&D) and other business units in support of global and local drug development, registration and marketing for assigned Therapeutic Area(s) for all stages of drug development. Furthermore you collaborate with relevant Clinical & Research Quality Assurance (CRQA)  members and M&D for alignment with company-wide standards. You also ensure quality oversight of M&D clinical trials (Phase I-IV) to maintain compliance with the international requirements for Good Clinical Practice (GCP) and other relevant (inter)national regulations. Next to that you are responsible for managing, conducting and/or participating in regional/global audits. You are responsible to manage an audit portfolio and provide technical expertise to identify and resolve quality issues. In this role you will travel domestic and international for 10-25%.   Your personal qualifications as a (Senior) Manager Clinical QA Bachelor’s degree Minimum of 3 years in pharmaceutical, biotechnology or related industry Minimum of 1 year significant experience in Clinical Quality Assurance Minimum of 2 years project management/clinical monitoring experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills As (Senior) Manager Clinical QA you have in-depth understanding of GCP requirements for both marketed and investigational products. Next to this you have demonstrated practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle. You are able to work independently with minimal supervision, you are stress resistant and you are a team player. As (Senior) Manager Clinical QA you have excellent interpersonal written and verbal communication skills in English. You are a self-starter, able to identify opportunities for improvement.   We offer A challenging and diversified job in an international setting Good career opportunities Inspiring work climate Attractive remuneration, which includes: a 13th month excellent pension policy health insurance compensation collective health insurance company own saving scheme arrangement 25 Holidays + 13 so called ADV Days and more…. At Astellas, we believe that nurturing a good relationship with our employees delivers good business results. It is our stated aim in the VISION for Astellas to be recognised as an Employer of Choice. This means ensuring we are a highly effective organisation, that applies best-in-class people management, creates a positive working environment and has an inspirational company culture.. This reflects the working culture of Astellas, outlines our expectations as an employer and captures the essence of our company ethos; CHANGING TOMORROW.   About Astellas Astellas is a Japanese multinational pharmaceutical company employing over 18,000 people worldwide with global sales exceeding 10billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and  sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. Astellas employs around 900 persons in the Netherlands, in Leiden and Meppel.   Mirai House, located in Leiden Bio Science Park, is home to a number of divisions, including the European R&D organization focusing on the development of medicines in the areas of Urology, Nephrology, Pain, and Diabetes/Metabolic diseases. It is the location where the majority of offices and clean rooms and labs are located.


Leiden The Netherlands

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