Associate QMS Manager
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V., we are searching for an Associate QMS Manager.
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.
As an Associate QMS Manager you will work under limited supervision or completely independent and in this role it will be your responsibility to implement operational plans for your region. You will support global audits and inspections and deliver on process improvement. You will also be involved at process compliance matters as well as KPI management and Metrics.
Delivering support to the management and maintenance of controlled safety documents like SOP are also included in your tasks. You will collaborate with relevant GPV and non GPV partners on a global level. Next to that you will participate in projects related to Audit and Inspection management and Process Improvement as well as Controlled Document management and/or Compliance management. You will be representing QMS and taking ownership for specific tasks and deliverables. You will make sure they are to ensure oversight as well as compliant with all applicable worldwide pharmacovigilance regulations and internal and external KPIs.
In this role you report to the Global Lead QMS or Process Improvement Team Lead.
Who we're looking for
We are looking for a BSc with at least 4 years within a pharmaceutical, biotechnology or related industry. You have at least 2 years’ of experience in Pharmacovigilance (e.g. in case processing), Regulatory affairs or Safety Quality Assurance, preferably experience in support of the safety quality systems. Thorough understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations.
- Experience and understanding of Process Management, Standards, Training & IT function as they apply throughout the entire pharmaceutical compound/product life cycle;
- Good understanding of PV and Clinical Research processes, and other processes making up the PV system, including the interfaces between these processes;
- Very good understanding of PV, data management and adverse event reporting and processing;
- Excellent oral and written communication skills, ability to interact with all levels of personnel;
- Must be able to communicate in English (active and passive), other languages considered an asset;
- Computer literacy (including Microsoft Office, Access and Project).
Additional vacancy information
Contract: Temporary contract with CLS Services
Contactperson: René Kemps
Phone: +31 (0)88 22 77 555