h3External Manufacturing – GMP Oversight CMO Management /h3pAre you an experienced Quality Operations professional (m/f/d) looking to take ownership in a global external manufacturing environment? /ppOur client is seeking a motivated Quality Operations Manager to provide quality oversight of Contract Manufacturing Organizations (CMOs) and ensure full compliance with cGMP and international regulatory standards for biologics drug substance and drug product manufacturing. /ppThe position is based in the french speaking part of Switzerland, within a dynamic cross-functional virtual plant team. Startin ASAP this is a temporary contract lasting 6 Months. /pbYour Responsibilities: /bulliProvide quality oversight of Contract Manufacturing Organizations (CMOs) /liliManage and review product disposition (batch documentation, deviations, change controls, complaints) /liliEnsure compliance with cGMP, regulatory filings and Quality Agreements /liliSupport inspections, audits and inspection readiness activities /liliEscalate quality risks and ensure timely resolution of compliance issues /li /ulbYour Profile: /bulliBachelor’s degree in a scientific discipline (e.g. Pharmacy, Biochemistry, Microbiology) /liliMinimum 4 years’ experience in pharmaceutical operations at the manufacturing site /liliAt least 2 years in quality, ideally in product release /liliExperience in biologics / sterile manufacturing and CMO oversight /liliStrong knowledge of cGMP, deviation management, CAPA and risk assessment /liliExperience with SAP/QMS systems and strong technical writing skills /liliFluent English required, German/Italian/French as a second preffered language /liliGerman basics /li /ul #J-18808-Ljbffr
Quality Operations Manager – External Manufacturing Arbeitgeber: gloor & lang ag
Unser Unternehmen ist ein führender Akteur in der pharmazeutischen Industrie und bietet eine dynamische Arbeitsumgebung in Boudry, wo Teamarbeit und Innovation gefördert werden. Wir legen großen Wert auf die berufliche Weiterentwicklung unserer Mitarbeiter und bieten zahlreiche Schulungs- und Wachstumsmöglichkeiten, um Ihre Karriere im Bereich Qualitätssicherung voranzutreiben. Mit einer hybriden Arbeitsweise und einem internationalen Umfeld sind wir bestrebt, ein unterstützendes und integratives Arbeitsklima zu schaffen, das es Ihnen ermöglicht, Ihre Fähigkeiten optimal einzubringen und weiterzuentwickeln.
