Do you have strong experience and skills in Quality Assurance and GDP auditing, combined with sound experience in existing and new pharmaceutical technologies? Then Astellas has an interesting job opportunity for you.
 
Associate Director Product Quality Management Leiden, full-time
 
Your job as an Associate Director Product Quality Management, GDP QA
As an Associate Director PQM, GDP QA you will act as the primary QA responsible for Storage and Distribution activities related to commercial products. You provide support for daily activities between Astellas and external third party logistics providers to ensure effective quality systems that meet GMP, GDP and established Astellas requirements. You support the Supply Chain organization in QMS activities such as change control, review and approval of transportation deviations, management review, business review meetings with LSPs, review and approval of procedural documents.
 
Travelling (typically 30%) will be on a global basis.

Your personal qualifications as an Associate Director Product Quality Management, GDP QA

• Science based degree (pharmacy preferred). Demonstrated relevant further education achievement, e.g. eligibility for QP, Lean Sigma black belt and/or MBA qualification. Member of professional bodies and/or associations.
• 10 years of experience of Quality Assurance and Quality Control in a manufacturing or supply chain environment, preferably in a European pharmaceutical company.
• At least 3-4 years of experience in a GDP QA role.
• Eligibility for Responsible Person (GDP) preferred.
• Self-starter and an experienced and respected QA professional.
• GxP Auditing experience and knowledge of GMP and QA systems.
• English speaking and writing.

As an Associate Director PQM, GDP QA you have problem solving skills and the ability to contribute to strategic planning. Furthermore, you have good communication skills, both written and spoken.

We offer  

• • A challenging and diversified job in an international setting
• • Good career opportunities
• • An inspiring and dynamic 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 recognized as an Employer of Choice. This means ensuring we are a highly effective organization, 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

Astellas is a Japanese multinational pharmaceutical company employing over 18,000 people worldwide with global sales exceeding 10 billion 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.