Pavia, Lombardy, Italy
Experienced in Oral Solid Dosage Technologies and Steriles; Quality and Production background. Project management and Leadership; Result Oriented; Cross functional team-working on continuous improvement projects.
Ensure cGMP and regulatory compliance of site functions, respecting European and International Regulations, Corporate Standards and Clients requirements through the guidance, coordination and control of the reporting structure,
Responsible for coordinating Solid dosage forms production and maintenance departments (approx. 160 people including direct labor) in compliance with GMP, regulatory and safety requirements and in line with service level and budget targets defined by the site Manager. I promote and facilitate continuous improvement initiatives aimed to increase quality, efficiency and costs, coordinating manufacturing business processes with strategic discussion within network for goal definition on long term planning.
Leading a multi site Technical Subteam for the assigned product, I provide overall technical leadership across the entire Roche DP SM manufacturing network (including external manufacturing) by giving technical oversight of the product and ensuring manufacturing process consistency, taking full ownership of the process/product health from a technical perspective and driving the process/product lifecycle strategy. The DPTL is a member of the Technical Product Team (TPT) and serves as a technical and manufacturing Single Point of Contact (SPOC) for the product.
Responsible for a cross functional team (including Production, Packaging, Quality, Engineering and Technical Operations functions) to manage the site supply chain (from raw materials incoming to FIGOs shipping) for different product families, managing about 60 people (including direct labor). I assure sponsorship and personal accountability to meet Strategic Targets (Quality- Supply- Safety & Cost), by applying Continuous Improvement, Problem Solving and Inclusion methodologies and behaviors.
Responsible for the Quality Group (Annual Review, Water Quality, Release- bulk and finished products, Complaint, Stability, Investigations, Training, Standard Operating procedures’ approval, validation), managing 7 direct reports. I have coordinated and supported Regulatory Inspections from Regulatory bodies (AIFA, Anvisa, Japan) and site FDA Certification