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Manager, bioanalytical systems & digital enablement

Fehraltorf
Celerion Switzerland AG
Inserat online seit: 19 Mai
Beschreibung

Manager, Bioanalytical Systems & Digital EnablementFor over 40 years, Celerion has stood the forefront of global bioanalytical contract research, partnering with pharmaceutical and biotech innovators to bring new therapies to patients faster. Our growing Fehraltorf/Zurich site it at the hear of that mission.THE OPPORTUNITYThe Manager, Bioanalytical Systems & Digital Enablement is responsible for coordinating global strategy, governance, and administration of bioanalytical laboratory systems and supporting digital platforms in close partnership with stakeholders.This role combines strategic coordination with hands-on operational execution, ensuring that global laboratory systems (e.G., LIMS, ELN, instrument integration) and operational tools are effectively implemented, utilized, compliant, and continuously optimized.Operating at the intersection of science, operations, and IT, this role:Facilitates development and execution of a globally aligned system strategy in collaboration with local stakeholdersActs as a hands-on system owner and administrator, supporting day-to-day operationsFacilitates alignment between US and Switzerland laboratories through partnership and shared decision-makingWorks closely with IT, Operations, QA, site teams and other functions to deliver integrated and practical solutionsThe position serves as both a global coordinator and working leader, accountable for enabling system performance, supporting project delivery, and day-to-day operational support, while ensuring that key decisions are made collaboratively with relevant stakeholders.Essential Functions:Responsible for staff management in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning anddirecting work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employeesStrategy, Governance, and ExecutionCo-develop the global roadmap for bioanalytical systems and digital platforms with input from site stakeholders and functional partnersEstablish governance that incorporate local requirements and stakeholder input while promoting standardization, scalability, and compliance across all sitesAct as both program lead and execution resource, facilitating alignment and consensus across stakeholders.Lead global implementations, upgrades, and migrations with active personal involvement where required and in collaboration with site teamsInterface with Celerion support teams and site representatives on implementation and utilization of business systemsSupport development and coordination of AI initiatives in partnership with operations and site stakeholdersHands-On System Administration & SupportDirectly administer and maintain laboratory systems (LIMS, ELN, CDS, and related platforms) as needed, in alignment with site requirements and governance processesManage user access, roles, and permissions in compliance with data integrity requirements and site leadershipMonitor system performance, troubleshoot issues, and resolve support tickets, coordinating with local users and support teamsSupport and/or perform system configuration, upgrades, patching, and integrations, ensuring stakeholder awareness and input where relevant Oversee and contribute to instrument integration and data flow between lab systems, working closely with site teamsMaintain system documentation and support audit and inspection readinessIntegration & Data FlowEnsure end-to-end data flow and visibility across the bioanalytical lifecycle in collaboration with system owners and site stakeholdersDrive integration across systems and platforms, balancing global standards with local operational needsIdentify and implement opportunities for automation and efficiency gains in partnership with users and functional teamsCollaboration & Cross-Site AlignmentFacilitate strong alignment between US and Switzerland laboratories through active stakeholder engagement and shared decision-makingAct as a key connector between IT, Bioanalytical Operations, QA, and other departmentsDrive global consistency while incorporating local input and constraintsFacilitate communication, prioritization, and execution across regions and functions, ensuring transparency in decision processesInnovation & Continuous ImprovementPromote adoption of AI, automation, and advanced analytics in collaboration with stakeholders and subject expertsEvaluate new technologies and manage vendor relationships incorporating cross-functional and site feedback into recommendationsDrive continuous improvement in system utilization, throughput, and data quality through joint initiatives with operational teamsCompliance & QualityEnsure compliance with GxP, 21 CFR Part 11, and data integrity requirements in partnership with QA and system stakeholdersSupport CSV activities and inspection readiness, working closely with QA and site representativesSupport audits and provide system documentation and evidence with input from relevant stakeholdersAdoption & Support ModelDrive user adoption through training and change management, in collaboration with site leadership and usersDefine and implement support models with input from global and local stakeholdersProvide leadership and serve as a technical escalation point, while coordinating with relevant teams for resolution and decision-makingKnowledge, Skills and ExperienceBachelor's degree in IT, Life Sciences, or related field (advanced degree preferred)8–12+ years of experience in bioanalytical, clinical research, or regulated environmentsStrong hands-on experience with:Laboratory systems (LIMS, ELN, CDS)System administration, configuration, and troubleshootingExperience leading system implementations and digital transformation initiativesDeep understanding of GxP compliance, data integrity, and validated systems (CSV)Proven ability to operate in both:Strategic leadership capacityHands-on technical execution roleExperience working across global teams (US and Europe preferred)Knowledge of data integration, automation, and AI/ML applications in lab environmentsStrong stakeholder management and cross-functional collaboration skillsWe look forward to your application. Kindly provide your resume in English. jid39c89f7a jit0623a jiy26a

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