A leading Global Pharma company are looking for an experienced QA leader to join their growing department at their plant in Norway.
The role of the Site Quality Assurance Director is to ensure all products and materials released from the manufacturing site adheres to international compliance standards.
You will responsible for leading a Quality Assurance organisation of 50 people in the areas of; The Quality Management System (QMS); Product certification and Releases; Quality Assurance budget and forecasts as well as reaching set targets.
The QMS must be continuously improved and to coincide with the company's global corporate procedures. You are to complete regular administration reviews on the QMS with the Site Management Team and manage all Regulatory Body inspections and audits.
You are also responsible to identify site quality policy and implementation within the facility.
For product release, it is your responsibility for the overall quality of finished products being released to the US and European market. It is essential international GMP guidelines are adhered to and all manufacturing processes are validated, and all documentation is completed.
The Site Quality Assurance Director is also responsible for creating the QA departments budgets and reaching site targets. The performance, development, and recruitment of the QA department is also key to this leadership role.
Key requirements of the QA Director include:
- Extensive knowledge of the pharmaceutical industry with Good Manufacturing Practice and (GMP), and Quality Management Systems.
- Experience in working in a highly-matrix organisation
- Success in implementing change-management methodologies and continuous improvement to a department in a manufacturing facility
- Leadership experience working with a management system according to ISO 9001 and ISO 13485
- University degree in Science
- Excellent command of the English language, written and oral