Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. And that’s the kind of work we want to be part of.
Are you looking for a unique opportunity to integrate a Greenfield project (building several new production lines) into the existing manufacturing environment? As Head Quality CQV you will be part of the Site Quality Leadership team, shaping the quality landscape at Lonza AG in Stein!
An agile career and dynamic working culture
Establish and maintain the Equipment Qualification System at Lonza Drug Product Services (DPS), including the commissioning, process and computerized systems validation, qualification of manufacturing equipment.
Lead and develop a team of QA Experts, guiding them in line with Lonza’s values and behaviors, including objective setting, performance evaluations, development planning, and participation in the recruiting process. Serve as the first contact for overarching documents related to equipment, infrastructure, and computerized systems qualification & maintenance within QA.
Supervise compliance activities such as GMP status and trending of equipment, qualification/re-qualification in relation to supplier qualification, changes, nonconformities, CAPAs, audit/inspection/self-inspection observations, and document management
Ensure decisions are fully supported by global and local Quality and Regulatory standards
Coordinate the qualification of equipment suppliers/services by supervising adherence to quality agreements and audit observations. Track GMP status of service providers, including calibration, maintenance, and consultants
Work experience in Quality Assurance
Solid experience in qualification topics within the pharmaceutical, GMP-controlled sterile manufacturing area, including solid CQV experience is crucial
Demonstrated assertiveness to uphold quality standards and make decisive calls in fast-paced environments with opposing priorities
Proficiency in English is a must; language skills in German are a plus