• Responsibility of finished product release within compliance to various markets: USA, EU, Israel, Japan and more.• Responsibility of lab incidents and lab investigation (out of specification, alert limits, atypical results).• Participation & leading of internal and external audits: FDA, MHRA, Israeli Ministry of Health, etc. • Updating & Implementation of Standard Operating Procedures (SOP).• Leading improvement teams based on OPEX methodology to improve operational processes within the lab and the site. (i.e. lean documentation, investigation cycle time, test reduction etc.)• Working with global interfaces: production, supply chain, QA, RA and laboratories.• Managing the finished product QC team, overseeing the professional development and personal welfare of the personnel. Responsibility of training & qualification, performance management, recruitment, etc. Direct manager of 4 team leaders and 40 analysts.

• Writing analytical methods and specifications or update existing documents, according to the requirements of health authorities, pharmacopeia’s updates, R&D and internal SOP.• Exposures to early stages of analytical/operational problems arise from the relevant interfaces (lab, QA, RA).• Adopting analytical methods based on laboratory’s capabilities and providing professional opinion for changes in analytical documents (method/specification).• Supporting these documents through all stages: preparation, approval by QA/RA, implementation in lab.

• Responsibility for batches release accordance to the specification and within compliance to regulatory requirements.• Review and approval of laboratory analysis.• Direct manager of 6 analysts.

• Analysis of finished product stability batches (extensive experience with HPLC)• Working according to protocols (including USP/EP)• Document lab results within compliance to GMP.