pThe bBachem Group /b is investing in a new planned site in Sisslerfeld in Northwestern Switzerland. This step is part of the long-term strategy to expand production capacity by the end of the decade. The new production site will play a central role in achieving these goals. The design phase of the project offers you unique opportunities to shape the future organization. /ppAs part of the development of our new Sisslerfeld manufacturing site, we are looking for a Lead QC Sisslerfeld Site Develepoment (a) 100%. In this key role, your focus will be to establish and lead the ramp-up of the Quality Control organization, driving the successful setup of laboratories, systems, and processes while ensuring regulatory compliance, operational readiness, and sustainable quality excellence. /ph3Your tasks /h3ulliBuild, lead, and continuously develop the Quality Control organization for the Sisslerfeld Site, including the establishment of Microbiology (MIBI) and In-Process Control (IPC) laboratories. /liliEnsure implementation of regulatory and compliance requirements and support alignment with internal and external stakeholders throughout project execution. /liliEstablish, implement, and continuously improve QC systems, processes, and the quality framework. /liliDrive qualification, validation, and implementation of analytical methods, technologies, equipment, and laboratory systems, including support of CQ activities (DQ, IQ, OQ, PQ). /liliDevelop and maintain the site documentation landscape in the area of responsibilities, including QC procedures, applicable regulations, roles, responsibilities, and documentation governance across all applicable areas. /liliDefine and coordinate operational readiness activities, milestones, and business processes to ensure successful transition from project to commercial operations. /liliOversee and continuously improve the ramp-up laboratory operations, QC processes, resource planning, and quality investigations (OOS, OOT, deviations, CAPAs, and change controls) during operational phase. /liliEnsure inspection readiness, represent Quality Control during audits and inspections, and collaborate with Global Quality and site stakeholders to drive continuous improvement initiatives. /li /ulh3Your profile /h3ulliPhD or MSc in a scientific discipline (Chemistry, Pharmacy, or a related field). /liliMinimum of 7 years of professional experience in the relevant field, including at least 5 years of leadership experience managing a team. /liliExperience interacting with Swissmedic and international regulatory authorities during audits and inspections. /liliIn-depth knowledge of regulatory requirements, including EU GMP Guidelines, the Swiss Therapeutic Products Act (HMG) and the Ordinance on Establishment Licences (AMBV), PIC/S Guidelines, ICH Guidelines, FDA requirements, and related regulations. /liliHigh level of commitment and dedication to the organization. /liliEnthusiasm for building and establishing a new GMP manufacturing site with a pioneering mindset. /liliStrong and effective communication skills. /liliExcellent organizational skills, with the ability to prioritize tasks and manage multiple responsibilities simultaneously. This is critical to supporting smooth site operations, especially during the project phase. /liliStrong problem-solving skills, with the ability to quickly identify issues, think analytically, and develop pragmatic yet compliant solutions to effectively address challenges. /liliFlexibility and adaptability, recognizing that priorities and responsibilities may change throughout different project phases. /liliExcellent written and spoken German and English language skills. /li /ulh3Our offer: /h3ulliA dynamic and rapidly growing work environment with internal development opportunities /liliEmployee development through numerous internal and external training opportunities /lili60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus /liliAccess to the benefits platforms with discounts from external partners /liliFresh, healthy and varied food in our staff restaurant /liliA wide range of free sports activities on the Bachem Campus /li /ul #J-18808-Ljbffr
Lead Quality Control (QC) - Sisslerfeld Site Develepoment (a) 100% Arbeitgeber: Bachem
Die Bachem AG ist ein hervorragender Arbeitgeber, der ein dynamisches und wachsendes Arbeitsumfeld bietet, in dem Mitarbeiter durch interne Weiterentwicklungs- und Weiterbildungsmöglichkeiten gefördert werden. Mit flexibler Arbeitszeitgestaltung, der Möglichkeit für Home-Office und einer firmeneigenen KITA am Standort Bubendorf schaffen wir eine familienfreundliche Atmosphäre, die die Work-Life-Balance unterstützt. Zudem profitieren unsere Mitarbeiter von attraktiven Zusatzleistungen wie einer 60%-igen Übernahme der Pensionskassenbeiträge und vielfältigen Sportaktivitäten auf dem Campus.
