Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge

Das ist der Job

pBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.

Darum lohnt es sich

Serve as a Subject Matter Expert (SME) and Facilitator for quality risk assessment, investigations, change control, and resolution of complex quality issues including review of regulatory CMC submission content. /ppFurther, this position will build and grow the knowledge management processes and tools to enable rapid access to data and knowledge over the entire product lifecycle in collaboration with the Product Data Quality team. /ppThis role requires a blend of technical expertise, leadership skills, and a proactive approach to quality and risk management as well as to continuous improvement. /ppbEssential Functions of the Job: /b /pliProcesses: Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and latest regulatory requirements on global level. /liliManage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality-related issues and incidents in an end-to-end process, including resulting from deviations, regulatory and/or GxP non-conformances or other quality events. /liliCross-Functional Collaboration: Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders to ensure timely and thorough management of GxP and quality incidents. /liliRoot Cause Analysis and CAPA management: Drive and support comprehensive root cause investigations.

Drive initiation and execution of market actions, if required. /liliRegulatory and GxP Compliance: Ensure that the Escalation and Notification to Management related activities and documentation meet the relevant regulatory agency and other relevant requirements for the industry (FDA, EMA, any local regulations, ISO, WHO); prepare for and support inspections and audits. /liliTraining Communication: Develop and deliver training on incident management procedures, share lessons learned from managed GxP/Quality incidents and promote a culture of quality and accountability across the organization. /liliMetrics Reporting: Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports. /lipbEducation and Experience Required: /b /pliBachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices). /liliMaster’s degree and 10+ years direct experience preferred /lipbSupervisory Responsibilities: /b /pli6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. /lipbComputer Skills: /b /pliStrong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc) /lipbOther Qualifications: /b /pliExperience with regulatory interactions including notification and communication with health authorities on global level for sensitive compliance topics. /lipbTravel: /b Up to 20% /pSalary Range Switzerland: 178,600.00 CHF - 223,300.00 CHFpGlobal Competencies /ppWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. /pliFosters Teamwork /liliProvides and Solicits Honest and Actionable Feedback /liliSelf-Awareness /liliActs Inclusively /liliDemonstrates Initiative /liliEntrepreneurial Mindset /liliContinuous Learning /liliEmbraces Change /liliResults-Oriented /liliAnalytical Thinking/Data Analysis /liliFinancial Excellence /liliCommunicates with Clarity /li When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. /ppbGeneral Description: /b /ppThe QMS Business Process Owner is responsible for managing assigned escalated GxP and Quality incidents in an end-to-end process on global level, initiating GxP/Quality incident prevention measures and maintaining (incl continuous improvement) of defined incident management related processes within regulated environments on global level.

GxP (Good Practices) guidelines are critical for ensuring product quality, safety, and regulatory compliance in the pharmaceutical / life sciences sector.

As BPO, the Director leads and oversees that quality incidents are managed effectively, root causes are identified, lessons learned are issued, and corrective and preventive actions (CAPAs) are developed to maintain the highest standards of compliance and patient safety and that the process operates for all BeOne operational groups. /ppAs BPO for Quality Risk Management (QRM) frameworks, ensuring compliance with regulatory requirements (e.g., ICH Q9).

Drive and oversee the development of corrective and preventive actions plans and lessons learned related to escalated GxP and Quality incidents.