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 Responsibilities
Strategic Leadership
Develop 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 Oversight
Own the global supplier and CMO Quality Management System (QMS).
Approve and maintain the global supplier/CMO portfolio, including:
Qualification and onboarding
Quality agreements
Performance monitoring and scorecards
Periodic business reviews
Compliance & Risk Management

Ensure 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 Improvement
Drive 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 events
Cross-Functional Collaboration
Partner with Procurement, Supply Chain, Regulatory, Development to ensure seamless operations and compliance.
Liase with Plant Supplier Qualification teams to identify synergies and streamline processes
Support the internal plants during regulatory inspections and internal/external audits.
Provide Quality leadership

Director, Global Supplier and External Manufacturing Quality

Ti assumiamo anche senza esperienza

Pizzaiolo

Ricevi nuove offerte di lavoro

Ricerchiamo operatori telefonici

Perito elettrotecnico - elettromeccanico