Director, Global Supplier and External Manufacturing Quality
8 ore fa
This senior leadership role is responsible for defining and executing the global quality strategy all Quality activities related to suppliers, contract manufacturers (CMOs), external partners, and outsourced operations across the full product lifecycle. The position ensures compliance with GMP, GDP, and applicable regulatory requirements while driving continuous improvement and operational excellence throughout the external supply network.Key ResponsibilitiesStrategic LeadershipDevelop and implement a global quality strategy for external manufacturing and suppliers aligned with corporate objectives and regulatory standards.Establish governance for supplier qualification, performance monitoring, and lifecycle management.Supplier & External Manufacturing OversightOwn the global supplier and CMO Quality Management System (QMS).Approve and maintain the global supplier/CMO portfolio, including:Qualification and onboardingQuality agreementsPerformance monitoring and scorecardsPeriodic business reviewsCompliance & Risk ManagementEnsure timely release of externally manufactured products.Oversee product quality reviews (PQR/APR) and device post‑market surveillance.Ensure adherence to GMP, GDP, ISO standards, and global regulatory requirements (FDA, EMA, ICH, PMDA).Oversee global audit programs and regulatory inspection readiness for external sites.Issue Resolution & Continuous ImprovementDrive investigations, CAPAs, and root cause analysis for deviations and complaints.Implement supplier improvement initiatives and risk mitigation strategies.Lead escalation and crisis management for supplier or CMO quality eventsCross-Functional CollaborationPartner with Procurement, Supply Chain, Regulatory, Development to ensure seamless operations and compliance.Liase with Plant Supplier Qualification teams to identify synergies and streamline processesSupport the internal plants during regulatory inspections and internal/external audits.Provide Quality leadership for strategic programs such as:New product introductionsNetwork expansionsDigital quality initiativesBuild and lead a global team of quality professionals, fostering a culture of accountability and excellence.QualificationsEducation: Degree in Life Sciences, Pharmacy, Chemistry, or Engineering; advanced degree (MBA or comparable) preferred.Experience:12+ years in pharmaceutical/CHC quality roles, with at least 2 years in global leadership.Proven experience in external manufacturing and supplier quality management.Proven experience in digital tools and eQMS system for the management of suppliersSkills:Deep knowledge of GMP, QMS, and regulatory frameworks.Strong leadership, negotiation, and stakeholder management skills.Other:Fluent in English; any additional languages a plus.Willingness to travel internationally (30–50%).#J-18808-Ljbffr
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Turbigo, Italia Alfasigma A tempo pienoThis senior leadership role is responsible for defining and executing the global quality strategy all Quality activities related to suppliers, contract manufacturers (CMOs), external partners, and outsourced operations across the full product lifecycle. The position ensures compliance with GMP, GDP, and applicable regulatory requirements while driving...
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Global Leader, Supplier
8 ore fa
Turbigo, Italia Altro A tempo pienoA leading pharmaceutical company in Italy is seeking an experienced Senior Leader in Quality Management. This role is critical for defining and executing the global quality strategy concerning suppliers and contract manufacturers. The ideal candidate will have over 12 years of experience in quality roles within the pharmaceutical sector and must possess...
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Global Supplier Quality Manager
5 giorni fa
Turbigo, Italia Hitachi Energy A tempo pienoA global technology leader is seeking a Supplier Quality Manager to enhance supplier management strategies. This position, available in Italy, requires a strong engineering background and extensive experience in supplier quality management. The ideal candidate will demonstrate effective leadership, outstanding negotiation skills, and proficiency in both...
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Global Supplier Quality Manager
4 giorni fa
turbigo, Italia Hitachi Energy A tempo pienoA global technology leader is seeking a Supplier Quality Manager to enhance supplier management strategies. This position, available in Italy, requires a strong engineering background and extensive experience in supplier quality management. The ideal candidate will demonstrate effective leadership, outstanding negotiation skills, and proficiency in both...
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Technical Project Manager
13 ore fa
Turbigo, Italia Recordati Industria Chimica e Farmaceutica S.p.A A tempo pienoJob Purpose The Technical Project Manager - External Manufacturing Governance (Pharma) is part of the External Manufacturing organization within Group Industrial Operations. The role is responsible for the strategic governance and cross-functional coordination of Contract Manufacturing Organizations (CMOs) projects, ensuring that external manufacturing...
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Supplier Quality Manager
5 giorni fa
turbigo, Italia Hitachi Energy A tempo pienoThe OpportunityPower Conversion Solutions (PCS) is a newly formed Global Product Group (GPG) within Hitachi Energy. PCS aims to become a high-performing, successful, and attractive partner for utilities, IPPs, and integrators by offering an unparalleled package of products, services, and software. Our mission is to drive profitable growth and deliver...
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Supplier Quality Manager
4 giorni fa
turbigo, Italia Hitachi Energy A tempo pienoThe OpportunityPower Conversion Solutions (PCS) is a newly formed Global Product Group (GPG) within Hitachi Energy. PCS aims to become a high-performing, successful, and attractive partner for utilities, IPPs, and integrators by offering an unparalleled package of products, services, and software. Our mission is to drive profitable growth and deliver...
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Supplier Quality Manager
5 giorni fa
Turbigo, Italia Hitachi Energy A tempo pienoThe Opportunity Power Conversion Solutions (PCS) is a newly formed Global Product Group (GPG) within Hitachi Energy. PCS aims to become a high-performing, successful, and attractive partner for utilities, IPPs, and integrators by offering an unparalleled package of products, services, and software. Our mission is to drive profitable growth and deliver...
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Supplier Quality Manager
6 giorni fa
Turbigo, Italia Hitachi Energy A tempo pienoThe Opportunity Power Conversion Solutions (PCS) is a newly formed Global Product Group (GPG) within Hitachi Energy. PCS aims to become a high-performing, successful, and attractive partner for utilities, IPPs, and integrators by offering an unparalleled package of products, services, and software. Our mission is to drive profitable growth and deliver...
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Technical Project Manager
13 ore fa
Turbigo, Italia Recordati A tempo pienoWith its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors...
