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Team Lead

vor 4 Wochen


Bezirk Stein SH, Schweiz Lonza Vollzeit

Today, Lonza is a global leader in life sciences operating across three 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.
Located in Stein our successful CDMO Business Unit Drug Product Services (DPS) offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Team Lead QA Operations, Growth Project 80 – 100% supporting our new sterile Drug Product facility.

Execute establishment and maintenance of the Quality Oversight at DPS Manufacturing (aseptic manufacturing, process simulations (APS), environmental sampling, proper qualification of DPS staff in aseptic techniques)
Lead and manage a team of at least 8 quality operations experts and develop them
Document Authoring, Review and approval including documents (e.g. batch records, SOPs)
Supervise and execute GMP compliance activities like changes, non-conformities, document management, e.g. last approver of major deviations for manufacturing incl. Establish and implement training and development plans
Counsel and support Sterile Production line functions, customers and groups in DPS like manufacturing, formulation and process development, business development in GMP compliance related issues in area of expertise
Write/Contribute to internal compliance policy and/or comment to regulations
Management and reporting of KPIs
Represent QA Operations in inspections, audits and local and global initiatives
Enforce adherence to GMP for sterile manufacturing/aseptic filling (acts as fist contact concerning compliance issues / quality alerts for local and shared systems)
Deputy of Head of QA Operations-Growth Project as required

10-15 years of professional experience in Quality Assurance and/or Quality Control in a manufacturing environment within the pharmaceutical Industry, preferably in Sterile manufacturing of drug products
~ Proven record of 2-4 years of people management, of more than 6-8 direct reports
~ Exceptional leadership and people management skills. Interpersonal savvy – capable of managing multiple points of view and building partnerships
~ Ability to handle ambiguity and complexity of Growth Projects is a plus
~ Able to coach and manage experienced and inexperienced staff
~ Fluency in English (spoken and written) is a must. At least B1 Level (spoken and written) in German is required