Senior Manager Quality Operations, Delegate RP/FvP

About the role

Bristol Myers Squibb is looking for a Senior Manager Quality Operations, Delegate RP/FvP, to support the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) in maintaining and improving the Quality Management System so that manufacturing and trading of medicinal products comply with Swiss and international GMP and GDP guidelines. The incumbent also releases batches in line with national and international GMP/GDP regulations, internal guidelines and the Quality Management System.

Key responsibilities

• Maintain and continuously improve the Quality Management System and ensure compliance with legal requirements
• Issue directives within the area of responsibility and ensure externally manufactured and traded products meet specifications, GMP and GDP requirements, and any national law requirements
• Perform supplier and customer checks, supplier qualification and Approved Supplier List activities
• Support recalls, self-inspections and audits (Health Authority and global), and supervise CAPA implementation
• Author or review SOPs and controlled documents, manage and investigate complaints, and raise, manage and investigate deviations with CAPAs
• Apply Quality Risk Management principles, collate KPIs and data, and report quality issues and suspected illegal trading to the RP/FvP and Swissmedic
• Manage quality-related master data in SAP, maintain product and supply chain knowledge, and manage Ship on Test forms
• Take part in GMP/GDP training, site and multi-site quality projects, and plant visits at Contract Manufacturing Organizations
• Lead or manage qualification/validation activities, perform technical GMP release and transfer to saleable stock, approve product redeployments and direct shipments, and authorise quality agreements with third parties
• Issue Notifications to Management (NTM)

Required profile

• Degree in Pharmacy, Chemistry, Biology, Chemical/Bio Engineering or equivalent
• Master's degree or higher with at least 5 years' experience, or Bachelor's degree with at least 7 years' experience in the pharmaceutical industry, with quality and compliance experience
• Previous experience as Responsible Person (FvP), including batch review and release, strongly preferred
• Fluent English; French and/or German preferred

Required skills

• Solid knowledge of cGMP (EU and US), EU GDP, PIC/S, ICH and other quality guidelines
• Quality Risk Management, CAPA development and investigation, and technical writing
• Experience with SAP, Veeva and electronic document management systems
• Good computer literacy (Word, Excel, PowerPoint, Outlook)