Position Summary The Senior Manager Quality Operations, Deputy of the RP/FvP will support the Responsible Person (RP)/Fachtechnisch verantwortliche Person (FvP) in the direct supervision, maintenance and continuous improvement of the Quality Management System to ensure manufacturing and trading operations comply with Swiss and international guidelines on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). The incumbent deputises the RP during absences, ensuring batches are released and compliance is maintained with all relevant regulations and BMS internal guidelines.
Duties / Responsibilities
Maintain and continuously improve the company’s Quality Management System to ensure ongoing compliance with legal requirements.
Have the authority to issue directives within the area of responsibility.
Ensure medicinal products manufactured and traded by the Swiss Branch of Swords Laboratories meet specifications and are produced and transported in accordance with GMP and GDP requirements.
Adhere to any additional national statutory requirements for specific products.
Perform supplier and customer bona fide checks to confirm all parties involved in manufacture, supply, storage or distribution are authorized.
Conduct supplier qualification and approved supplier list activities.
Support the coordination and execution of recall operations for medicinal products under Swords Boudry oversight.
Lead or support self‑inspections conducted at regular intervals, implementing necessary corrective measures.
Author or review SOPs and other controlled documents related to technical/GMP batch release and release to saleable stock.
Investigate relevant customer or technical complaints as required.
Apply Quality Risk Management principles for risk assessment, control, communication and review, performing risk assessments as necessary.
Raise, manage, approve and investigate deviations, including transport deviations, ensuring documentation and implementing corrective and preventive actions (CAPAs) in line with quality risk management principles.
Collate KPIs and data for periodic evaluation of the effectiveness of the Quality Management System.
Support local health authority inspections and global BMS audits, including preparation, coordination, and follow‑up activities; supervise CAPA implementation in collaboration with the RP/FvP.
Participate in courses, seminars, or congresses focusing on GMP/GDP regulatory requirements and industry trends for continuous professional development.
Lead or participate in site and multi‑site quality projects involving Swords Boudry.
Participate in plant visits at contract manufacturing organizations.
Support qualification/validation activities for Swords Boudry GMP/GDP operations, systems or software.
Perform technical/GMP release and transfer to saleable stock of non‑ready‑to‑use and ready‑to‑use medicinal products, independently from management and commercial functions.
Approve product redeployments and direct shipments.
Author and review quality agreements with third parties and internal sites covering outsourced or delegated activities.
Issue notifications to management (NTM).
Maintain and approve quality‑related master data in SAP.
Report quality issues and suspicion of illegal trading to the RP/FvP and support notifications to Swissmedic within stipulated deadlines.
Maintain up‑to‑date knowledge of product and supply chain for all technically released products.
Manage and approve ‘Ship on Test’ (Shipments under Quarantine) forms.
Decide on final disposition of returned and rejected products.
Manage product defect notifications and communicate with Swissmedic where mandatory.
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Duties / Responsibilities
Maintain and continuously improve the company’s Quality Management System to ensure ongoing compliance with legal requirements.
Have the authority to issue directives within the area of responsibility.
Ensure medicinal products manufactured and traded by the Swiss Branch of Swords Laboratories meet specifications and are produced and transported in accordance with GMP and GDP requirements.
Adhere to any additional national statutory requirements for specific products.
Perform supplier and customer bona fide checks to confirm all parties involved in manufacture, supply, storage or distribution are authorized.
Conduct supplier qualification and approved supplier list activities.
Support the coordination and execution of recall operations for medicinal products under Swords Boudry oversight.
Lead or support self‑inspections conducted at regular intervals, implementing necessary corrective measures.
Author or review SOPs and other controlled documents related to technical/GMP batch release and release to saleable stock.
Investigate relevant customer or technical complaints as required.
Apply Quality Risk Management principles for risk assessment, control, communication and review, performing risk assessments as necessary.
Raise, manage, approve and investigate deviations, including transport deviations, ensuring documentation and implementing corrective and preventive actions (CAPAs) in line with quality risk management principles.
Collate KPIs and data for periodic evaluation of the effectiveness of the Quality Management System.
Support local health authority inspections and global BMS audits, including preparation, coordination, and follow‑up activities; supervise CAPA implementation in collaboration with the RP/FvP.
Participate in courses, seminars, or congresses focusing on GMP/GDP regulatory requirements and industry trends for continuous professional development.
Lead or participate in site and multi‑site quality projects involving Swords Boudry.
Participate in plant visits at contract manufacturing organizations.
Support qualification/validation activities for Swords Boudry GMP/GDP operations, systems or software.
Perform technical/GMP release and transfer to saleable stock of non‑ready‑to‑use and ready‑to‑use medicinal products, independently from management and commercial functions.
Approve product redeployments and direct shipments.
Author and review quality agreements with third parties and internal sites covering outsourced or delegated activities.
Issue notifications to management (NTM).
Maintain and approve quality‑related master data in SAP.
Report quality issues and suspicion of illegal trading to the RP/FvP and support notifications to Swissmedic within stipulated deadlines.
Maintain up‑to‑date knowledge of product and supply chain for all technically released products.
Manage and approve ‘Ship on Test’ (Shipments under Quarantine) forms.
Decide on final disposition of returned and rejected products.
Manage product defect notifications and communicate with Swissmedic where mandatory.
Approve mandatory mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mandatory mandatory Mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand mand
#J-18808-Ljbffr
Senior Manager Quality Operations, Deputy RP/FvP Arbeitgeber: Bristol Myers Squibb EU Policy
Bristol-Myers Squibb ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Deutschland und Österreich nicht nur ein dynamisches Arbeitsumfeld bietet, sondern auch die Möglichkeit zur beruflichen Weiterentwicklung innerhalb eines globalen Unternehmens. Mit einer flexiblen Arbeitsgestaltung, die bis zu 50% Remote-Arbeit ermöglicht, und einem starken Fokus auf Mitarbeiterzufriedenheit und -engagement, fördert das Unternehmen eine positive Unternehmenskultur, die auf Zusammenarbeit und Unterstützung basiert.
Kontaktdaten:
Bristol Myers Squibb EU Policy Recruiting-Team
