You will be leading the Quality Microbiological Lab and you will be responsible for:
Managing employees of the Laboratory (around 30 indirect reports and 4 direct reports) Managing the activities of the Microbiological laboratory (incl. raw materials, intermediate and end products testing, deviations, calibration and validation of equipment, method development, stability programs, cGXP, safety, budget) Coordinating with Quality Leadership as an active member of the Quality Management Team (incl. long-term local strategy, interaction on global platforms, translating global objectives into local objectives as well as sharing best practices) Representing the Site during regulatory authority inspections and from a quality perspective to customers, professional and trade organizations, the public and other external sources. How you’ll spend your dayManage Quality
Lead the site's Analytical Microbiological laboratory team in establishing and maintaining quality at the lab in accordance with Site SOP’s, regulatory guidelines and cGXP compliance requirements. Maintain high standards of quality at the lab through managing and continuously improving the effectiveness of laboratory quality processes and systems.
Manage Team and Resources
Sustainable Culture of Quality
Influence Beyond the Site
Share best practices, challenges and lessons learned within the site across the Quality organization in order to improve the performance of quality globally. Your experience and qualifications University level (Pharmacy / Analytical ChemistryMicrobiology) or HBO+ with several years of experience in a manager position in the pharmaceutical industry Excellent people management and communication skills Experience in the pharmaceutical industry (preferably sterile manufacturing), analysis techniques and cGXP Capability to handle Regulatory authority inspections Knowledge of cGXPs and relevant regulatory guidances Ability to promote continuous process improvement/ efficiency Credibility and proactive orientation Problem-solving and result-driven attitude Confident decision-makerContact person
Ivo Huijskens - Senior Recruiter Europe
Reports ToSite Quality Head
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