Manager, Lab Systems

Job content

• The candidate for this role can be based in any of our Operating Companies in the US or EU.
  
  

• eLIMS data management for Janssen site’s. Ensures on time & high quality of master data upload in LIMS for all Janssen activities. The eLIMS CoE has the responsibility to take the final quality approval of all Master Data, errors in Master Data can lead to escalations & recalls
• Leading a staff of different master data & Technical expert employees and supervisors, responsible for their development and training to meet the current and future business needs. The staff participates directly or indirectly on project teams to develop, consolidate and/or improve eLIMS processes.
• Govern and coordinate CoE processes in region, drive harmonization and standardization across the 3 regions and manage implementation of improvement initiatives.
• Accountable for process performance and compliance with internal guidelines
• Setting priorities aligned with local site needs and internal global procedures to obtain optimized efficiency.
• The ideal candidate for this position is able to lead digital transformation projects to digitalize and automate eLIMS master data processes. And can translate new business requirements for NPI’s into eLIMS master data.
• Leading external integration projects to design LIMS2LIMS connections in partnership with IT for J&J testing done at ECLs and CMO’s.
  
  

• Provide leadership in regional eLIMS CoE responsible for all eLIMS & iLABS master data upload. Partner with IT, local lab teams, compliance experts, etc. in support of a correct, harmonized & lean master data upload.
• Prioritize CoE actions based on global and local requirements resulting in OTD support to local labs
• Ensure performance of eLIMS CoE is aligned with target performance KPIs
• Manage capability development for the eLIMS CoE team
  
  

• Direct, manage, and coach staff members. Ensure alignment of department objectives and activities with QC Ops & JSC Q strategic objectives. Ensure that each staff member has clearly established goals and objectives, monitor staff performance, conduct periodic performance evaluations and salary planning, and ensure succession planning for key positions, including own.
• Management duties for indirect reports (Off shore external partner for master data upload)
• coaching, establishment of targets & objectives, progress & performance monitoring.
• Management duties for indirect reports (master data site teams)
• establishment of targets & progress monitoring
  
  

• Lead eLIMS projects, integrate direction of LT QC Operations & JSC Q, ensures appropriate metrics are defined and measured to enable monitoring and continuous improvement.
  
  

• A minimum of a Bachelor’s or Master degree required
• A minimum of 5 years of experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) is required.
• Demonstrated experience directly and/or indirectly leading a group of professionals to achieve business objectives is preferred. Flexible and capable of leading people over distance is required.
• Knowledge of LIMS is mandatory
• Ability to engage others and lead an organization through continuous improvement and change. Ability to negotiate, influence and lead with or without direct line authority.
• Thorough knowledge of complex master data & global regulatory requirements applicable to pharmaceuticals, biologics, and APIs.
• Demonstrated understanding of basic laboratory processes and compliance requirements
• Excellent written and verbal communication skills (English – C1) are required
• Strong Problem-solving and Change management skills are required
• Lean-approach oriented is preferred
• Excellent negotiation, partnering and influencing skills are required.
• Direct working knowledge of the business environment outside of the quality organization (e.g., manufacturing, supply chain processes,…) is preferred
• Ability to build and nurture strong, positive relationships with business leadership, customers and partners in Lab Systems, IT, Manufacturing and other Quality functional groups is required.