Description

QC Manager  Role level: M3 - within Annamaria Spano's department. Your role: An exciting opportunity has arisen to join the Quality Control of Aubonne Bio-manufacturing Plant. Enter a new era while entering new QC facilities, join the QC team as Quality Control Analytical Support & Technology Manager and contribute to deliver a consistent supply of quality medicines to patients. As QC Analytical Support & Technology Manager, you lead 40+ collaborators dedicated to the sampling raw materials, utilities, Drug Substance and Drug Product; coordinating external analysis and qualification of all QC equipment; executing Tech Transfer and Covalidation of Anaytical Method from Merck Guidonia.  Purpose of the role: To manage the QC AS&T Laboratory and ensure that all related activities are performed in accordance with the cGMPs and regulatory requirements.To ensure a consistent customer focused analytical service.To guarantee the supply of quality products according to the established plan, good manufacturing practices, product registration, site quality standards, and manage within agreed financial limits.To ensure the use of validated/qualified analytical methods and equipment.To ensure the availability of a reliable and accurate documentation in the laboratory.To support the transfer or implementation of new analytical test methods.To support the transfer of production processes including validation batches according to company needs.To drive or participate in the continuous improvement programs in the laboratory, department and site.To generate the analytical part of the registered files in collaboration with the regulatory functions.To foster multiskilling in the laboratory.To ensure of the integrity of the data created in conformity with the « Data Integrity rules ».  As a -go-to" Manager, you ensure the above is performed in accordance with the cGMPs, regulatory requirements and company standards. You also successfully present and/or defend all the above in Inspection or Audit. You will report to the Head of Quality Control, you liaise with peer QA and QC and production managers and you allow the QC testing labs to run smoothly whilst managing experienced collaborators eager to develop (themselves, the team, the company) in a context of growth, simplification, and changes.  Who you are:5+ years of experience in QC activities in relation with Biotechnology processing in GMP environmentProven ability to learn & adapt quicklyProven experience as supervisor/manager with leadership skills Team player with advanced communication skills in French & EnglishAwareness of pharmaceutical and regulatory requirementsPrevious successful experience in positions interacting with other departments/sites