Quality Manager Global Biopharma

Quality Manager Global BiopharmaSteriles - QA Operations - 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. This contract will last 12 months. Starting date is ASAP.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 language jid69642aba jit0208a jiy26a