At STADA we pursue the purpose of "Taking care of people's health as a trusted partner." Generics, Consumer Healthcare and Specialties, we offer patients, doctors and pharmacists a wide range of therapeutic options.
Manager Global Technology Transfer is responsible for leading end-to-end Technology Transfer execution providing Project Management, scientific and technical expertise, e.g., in quality, technology transfer, regulatory.
Lead and manage Tech Transfer projects effectively and independently, ensuring deliverables are completed in time, at agreed costs and carefully balancing benefits & risks
*Define Project strategy, Project Team and create end-to-end Project Plan capturing project risks including mitigation strategy
*Coordinate cross-functional Project Team across internal stakeholders (Global and local TechOps functions: QA, QC, AS&T, MS&T, ESO, RA, Commercial Transfer Team), as well as the third parties when involved in the project scope (CMOs) e.g. transfer Projects to the Contract Manufacturer
*Run project meetings to monitor project milestones, track project execution and report on progres
*Ensure cross-functional alignment and joint decision-making, define actions in project meetings and follow up on execution with project team members
*in quality, regulatory, tech transfer and resolve issues which occur as part of daily business to ensure cross-functional information flow on the way to adhere to the project schedule
*Check that content of GMP documents is correct and complete and in compliance with the dossiers
*Write Product Performance Review – Report after feasibility trials that summarizes conclusions and recommendation for validation batches
*Prepare the updates to Module 3 according to technology transfer results
*Prepare the variation documentation in accordance with local regulatory requirements of impacted countries
*Support product launches from the new site following transfer in cooperation with Commercial Transfer Team, Supply Chain, QA, RA.
Fluent in English (written and spoken)
*More than 5 years of work experience in Pharma Industry (in depth knowledge preferably in technology transfers, product development, manufacturing, or regulatory affairs). It can independently manage all areas of Tech Transfer Projects: quality, regulatory and technical
*Project management experience and capability to lead multi-functional teams
*Business/market/technology savvy - understanding business and impact on business
*STADA offers a competitive environment for personal and professional development in a growing company full of opportunities.
Our future project requires dynamic and proactive professionals, capable of adding value in a changing environment.