DIRECTOR PHARMACOVIGILANCE QA

INFORMATIE

Bedrijf Astellas Pharma Europe B.V.
Geplaatst op 04/04/2019
Standplaats Leiden
Werklocatie Leiden
Provincie Zuid-Holland
Aantal uren per week 40 uur
Dienstverband Vast
Carriereniveau Senior management
Opleidingsniveau HBO

FUNCTIEOMSCHRIJVING


Do you have broad experience in the pharmaceutical industry, combined with experience in managing a Quality System within a GxP environment? Then Astellas has an interesting job opportunity for you.

Director Pharmacovigilance QA

Leiden, full-time

Your job as a Director Pharmacovigilance QA

As a Director Pharmacovigilance QA you will partner with peers in other regions to provide leadership and strategic direction to the global Pharmacovigilance Quality Assurance team which is responsible for QA oversight of Pharmacovigilance system activities to ensure compliance with (inter)national regulatory requirements for Good Pharmacovigilance Practice (GPVP/GVP). Your main responsibilities are:

  • Developing, managing and allocating resources for execution of the PV audit schedule for license partners, internal audits and vendors in conjunction with stakeholders to ensure an effective audit program.
  • Coordinating leadership, development, mentoring and support for direct reports.
  • Acting as Primary Inspection Administrator for the facilitation and management of regulatory agency inspections and customer/license partner audits.
  • Ensuring appropriate implementation of corrective actions and quality system improvements.
  • Leading an effective escalation process for management of deviations, analysis of risk and measuring effectiveness.
  • Developing short and long-term risk-based quality strategies in support of pharmacovigilance activities.
  • Providing forecasts and budget reports.


Your personal qualifications as a Director Pharmacovigilance QA

  • BA / BS or equivalent, with 10+ years of industry experience, 5-7 years of QA experience and 3-5 years managing staff.
  • Experience in managing a Quality System within a GxP environment.
  • Comprehensive knowledge of GxP and other regulations for pharmaceuticals and biologics and understanding of global quality standards and regulatory authority inspection trends.
  • Demonstrated experience in hosting and facilitating regulatory agency inspections and customer/license partner audits with successful outcomes.
  • Demonstrated ability to establish local and regional Quality policies and to influence the development and implementation of global Quality policies.
  • Demonstrated ability to translate external and internal quality and compliance trends into QA practice.


As a Director Pharmacovigilance you have strong leadership and organizational skills with the ability to initiate, build and maintain strong cross-functional and cross-divisional business relationships. You are capable to work effectively within a global environment and have excellent interpersonal and communication skills. It will be highly preferred if you have current certification or credential as a qualified auditor from a recognized national or international quality organization, but it is not required.

We offer

  • A challenging and diversified job in an international setting
  • Good career opportunities
  • Inspiring 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 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.

About Astellas

Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 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 950 persons in the Netherlands, in Leiden and Meppel.

Interested?

Please apply via the 'Apply' button. A VOG and/or background check can be part of the recruitment process.

Agency calls are not appreciated.