• Supervise implementation of quality strategy and processes.• Responsible for all quality and compliance related decisions, and for implementation of all quality management programs.• Ensure that local quality systems and products are compliant with GMP standards and health regulations.• Advocate for continuous improvement during manufacturing, distribution and shelf life for the products manufactured.• Supervise effectiveness of quality systems, including performance of self-inspections, metrics monitoring and participation in management reviews.• Establishment of appropriate interface with authorities for any GxP related activity and ensure appropriate and timely notification of quality related matters.

Direction of the Production Unit of the site:• Planning, direction and monitoring of production activities to achieve established plans and meeting quality standards• Prioritize work/projects to ensure that critical activities occur in a timely manner• Allocation of labor and capital resources to maximize productivity. • Liaise with other areas to plan current and future production needs and minimize disruptions to manufacturing schedules.

• Management of MS&T team in 2 production sites• Definition of department priorities and alignment with other site and global organization functions• Talent & team development• Active involvement in strategic decisions impacting 2 production sitesOperational objectives:• Keep and improve the technical knowledge of production processes for oral and sterile penicillin and macrolide semisynthetic derivatives.• Optimization of processes, yields and costs. Reduction of write-offs.• Assurance of process robustness through monitoring and statistical data analysis.• Overview of validation of production, cleaning and analytical procedures.• Close cooperation with other technical departments for investigation of process deviations and identification of main contributing factors for product failure.Other:Management of inspections from health authorities (FDA, EMEA, Brazil,…) on site

•Implementation of Ideas Management Program on site.•Program promotion and monitoring through KPI’s

•Management of R&D/LCM team in 2 production sites•Optimization of chemical processes•Investigation of production deviations•Technical guidance to Quality Assurance and Regulatory Affairs departments

•Synthesis/Development of new chemical products and processes.•Filling of Regulatory Technical documents (DMF,CEP).•Pilot plant/scale up studies of new chemical processes.•Development of new HPLC and HPLC-MS analytical methods.•Performance of stability studies (stress, accelerated and long-term).•Identification and characterization of impurities of Active Pharmaceutical Ingredients.•Patent evaluation for development of Active Pharmaceutical Ingredients.