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Associate Director Product Quality Management, GDP QA

Research / Academic
Leiden

Description:

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.

Requirements:

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.

Salary Benefits:

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.

Work Hours:

40 hours per week

Address:

Sylviusweg 62