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Posted on : 13 May 2017
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.
- 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
We believe that nurturing a good relationship with our employees delivers good business results.
- It is our stated aim in the VISION for our company 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 our company, outlines our expectations as an employer and captures the essence of our company ethos.
- Our company is a Japanese multinational pharmaceutical company employing over 18,000 people worldwide with global sales exceeding 10 billion euro.
- The group s EMEA headquarters affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing.
- With over 4,500 employees, EMEA is an important and growing 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.
Leiden The Netherlands
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