Operations And Outsourcing Group Lead, Bioanalytics
Current- Manages the overall operations of the Bioanalytics laboratories and is responsible for implementing and maintaining systems and procedures to help ensure GMP/GLP compliance of the laboratory and operational efficiency of all GMP and non GMP labs. - Prepares for and participates in laboratory audits, interprets audit responses and collaborates with BioA management and QA to address concerns raised from audits. - Leads a team of ~ 10 people responsible for coordinating general laboratory activities, instrument qualification and maintenance, tracks samples and reagents, updates laboratory metrics databases, manages SOPs, and maintains the departmental operations and compliance systems and resources. - Acts as the primary contact for all outsourcing needs in the department from initiating contracts, resolving concerns and coordinating between analytical leads, CROs and purchasing departments at Sanofi. - Acts as a project manager and departmental representative responsible for the assessment and implementation of new automated systems (e.g. ELN, LIMS and CDS) and procedures. This includes coordinating across global Sanofi departments and external representatives, and matrix managing a team of departmental personnel. After implementation of an automated system, works with their subordinates and other laboratory personnel to ensure that all BioA analysts are adequately trained to minimize the impact of introducing a new system into the workflow. - Oversees the GMP training for all GMP teams and analytical team leaders working with the QA and iLearn teams. - Leads BioA infrastructure projects and laboratory moves to ensure all GMP systems are designed and implemented appropriately, including overseeing the equipment validation, change controls and associated documentation.- Oversees the equipment maintenance, validation and calibration program for BioA by collaborating with Metrology, Validations SCO and external vendors.
