Quality Unit Lead - Manufacturing Site Garbagnate (m/f)

• Manage the continuous development of effective Quality processes
• Ensure continuous improvement of Cost of Goods (COGs) and Operational Excellence

• Lead development of Quality Unit team, applying VACC leadership behaviors- Visionary, Architect, Catalyst, and Coach- to drive engagement and performance while also championing people development across the site and promoting talent

• Facilitate knowledge sharing and experience exchange across the global Quality community
• Manage the Quality Unit in compliance with EU GMP directives and internal standards
• Represent the Quality Unit within the Site Leadership Team, during inspections (by authorities and third parties), interactions with the works council, investment projects, and cross-functional or cross-site teams
• Ensure compliant, reliable, and cost-effective execution of all quality-related operations, including sampling and release of incoming materials (APIs, excipients, packaging), production, quality control, and release of bulk and finished products
• Oversee quality-related activities at the logistics center, ensuring GDP compliance
• Ensure effective monitoring of the environment and utilities (biological and physical) in production areas
• Identify and implement improvements in product quality, processes, variability reduction, and innovation, as well as enhancements to the pharmaceutical quality system
• Handle product complaints and counterfeit cases in accordance with Bayer policies
• Manage the quality aspects of the pharmaceutical change control system and compile Product Quality Reviews (PQRs)
• Develop and implement a strategy for organizational development to strengthen Quality Culture and promote a balanced approach to risk-taking and risk mitigation
• Support the Crisis Management Committee by analyzing emergency impacts on product quality and compliance, and by managing communication with media, regulatory bodies, and corporate stakeholders
• Ensure the establishment, maintenance, and monitoring of the Business Continuity Plan (BCP) for the Garbagnate site
• Ensure, in collaboration with the HSE department, compliance with relevant standards and management systems (e.g. UNI ISO 45001, UNI EN ISO 14001, UNI CEI EN ISO 50001)
• Act as a proxy with delegated authority for relations with Ministries and Public Administration, and for technical and ordinary correspondence

• Degree in sciences (e.g. chemistry) or pharmacy
• At least 10 years of operational experience and leadership in Quality and/or manufacturing, certification as a Qualified Person is a plus
• Experience working internationally or across different Supply Centers/Sites is a plus
• Excellent knowledge and application of cGMP and regulatory compliance (US, EU and other international agencies)
• Deep understanding of Finance KPI's, COGS calculations and P&L
• Strong Project management experience with a history of delivery to schedule
• Strong stakeholder management and cross-functional partnering skills across businesses, functions, and geography
• Experience managing change across international contexts, leveraging VACC leadership behaviors and a strong foundation in self- and system-awareness
• Strategic thinking integrated with deep business and external market insights
• Achievement of high-impact results across pipeline, teams, talent, and organizational

• Accountable collaboration within and across teams to achieve shared objectives
• Customer-focused co-creation to align solutions with stakeholder needs
• Agile execution through 90-day cycles, emphasizing rapid learning and continuous

• Leadership approach that fosters authenticity, purpose, inclusion, and diversity
• Dynamic talent allocation responsive to changing business demands
• Residence or domicile in Lombardy
• Fluency in English and Italian mother tongue

Bayer