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(Sr.) Manager CQA Leiden Netherlands,  

Astellas (company)

Posted on : 07 May 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 our company  has an interesting job opportunity for you!             

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 company  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 

About Us:
  • Our company  is a Japanese multinational pharmaceutical company employing over 18,000 people worldwide with global sales exceeding billion euro. 
  • The group s EMEA headquarters,  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 company  region, having key strengths in the therapy areas of Urology, Transplantation, Anti Ineffective, 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.
  • Our company  employs around 900 persons.


Leiden The Netherlands

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