External Manufacturing – GMP Oversight & CMO ManagementAre you an experienced Quality Operations professional (m/f/d) looking to take ownership in a global external manufacturing environment?Our 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.The 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.Your Responsibilities:Provide quality oversight of Contract Manufacturing Organizations (CMOs)Manage and review product disposition (batch documentation, deviations, change controls, complaints)Ensure compliance with cGMP, regulatory filings and Quality AgreementsSupport inspections, audits and inspection readiness activitiesEscalate quality risks and ensure timely resolution of compliance issuesYour Profile:Bachelor’s degree in a scientific discipline (e.g. Pharmacy, Biochemistry, Microbiology)Minimum 4 years’ experience in pharmaceutical operations at the manufacturing siteAt least 2 years in quality, ideally in product releaseExperience in biologics / sterile manufacturing and CMO oversightStrong knowledge of cGMP, deviation management, CAPA and risk assessmentExperience with SAP/QMS systems and strong technical writing skillsFluent English required, German/Italian/French as a second preffered languageGerman basics #J-18808-Ljbffr
Quality Operations Manager – External Manufacturing in Neuenburg am Rhein 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.