Quality Unit Lead - Manufacturing Site Garbagnate (m/f)
Bayer HealthCare Manufacturing is looking for a brilliant and visionary Quality Unit Lead to join our manufacturing site in Garbagnate Milanese (MI).
He/she will be responsible for leading all quality-related functions across the site, including the pharmaceutical regulatory function, ensuring full compliance with regulatory requirements, Bayer standards, and applicable laws.
He/she will also guarantee the effective management of the Quality Unit in accordance with Legislative Decree 231/01, Decree Law 81/2008, Decree Law 152/06, as well as the Bayer Corporate Compliance Policy and local guidelines, while upholding the highest levels of product quality, patient safety, and operational integrity.
MAIN TASKS AND RESPONSIBILITIES:
• Manage the continuous development of effective Quality processes
• Ensure continuous improvement of Cost of Goods (COGs) and Operational Excellence
in relation to work processes, tools, and skills (PSS)
• 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
exchange within SC Gar clusters and the global Quality network
• 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
WHO YOU ARE:
• 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
objectives
• 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
adaptation
• 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
Location: Garbagnate Milanese
Type of contract: Permanent
HROP_Italy@bayer.com