Senior Manager / Associate Director Electronic Systems QA - Netherlands
Are you a Quality Assurance professionals and do you have extensive knowledge in electronic systems, combined with auditing experience? Then Astellas has an interesting job opportunity for you!
Senior Manager / Associate Director Electronic Systems QA
Leiden, The Netherlands, Fulltime, 40 hours
Your job as a Senior Manager / Associate Director Electronic Systems QA
As a Senior Manager / Associate Director ESQA you are part of a dynamic and innovative department within Astellas. You will represent ESQA on system development life cycle and validation project teams and help drive eSource / data integrity compliance initiatives. Your responsibilities are (strategic) management and oversight of the electronic systems quality assurance and validation oversight programs related to Astellas Information Systems and clinical operations. As Astellas continually invests in new processes in R&D computerized systems, you will contribute to develop, facilitate and implement process improvements and support new technology initiatives and ensure compliance with global Electronic Records / Electronic Signatures regulations.
Furthermore, you are lead in internal audits as well as external audits of computerized systems. Because of these responsibilities, it is important to develop and maintain effective business relationships with internal and external stakeholders. The Senior Manager / Associate Director ESQA is always seeking for the right collaborations and partnerships.
Your personal qualifications as a Senior Manager / Associate Director Electronic Systems QA
- Bachelor of Arts of Bachelor of Science degree
- Minimum of 7 years of experience in in the pharmaceutical industry
- Minimum of 5 years of experience in quality assurance in the pharmaceutical industry
- Experience in performing or overseeing software / system development life cycle and computer system validation
- Proficiency in Microsoft Office (with focus on Access)
As a Senior Manager / Associate Director ESQA you are experienced in Quality Assurance, Electronic Records/ Electronic Signatures regulatory compliance, and eSource / Data integrity compliance in multicultural and global settings. You have in-depth knowledge of GxP regulations and computerized systems in GxP regulated environments, related to clinical product development combined with knowledge of quality principals and industry trends. You know the global industry standards and regulatory requirements for software development, computer system validation, Electronic Records and Electronic Signatures regulations. The ideal candidate has strong interpersonal skills and multi-cultural awareness to be able to develop and maintain effective business relationships with stakeholders. With excellent oral and written communication skills, leadership and organizational skills you are used to leading project teams and giving presentations. Because of your responsibilities in auditing, domestic and international travel of 15-20% is required.
A challenging job in an out of the box thinking team
· Good career opportunities
· Inspiring work climate in an innovative and dynamic department
· 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.
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