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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.
Job Responsibility:
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
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
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
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
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 for strategic programs such as: New product introductions
Network expansions
Supplier consolidation
Digital quality initiatives
Build and lead a global team of quality professionals, fostering a culture of accountability and excellence
Requirements:
Degree in Life Sciences, Pharmacy, Chemistry, or Engineering
advanced degree (MBA or comparable) preferred
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 suppliers
Deep knowledge of GMP, QMS, and regulatory frameworks
Strong leadership, negotiation, and stakeholder management skills
Fluent in English
any additional languages a plus
Willingness to travel internationally (30–50%)
What we offer:
competitive salary
comprehensive benefits
extensive opportunities for professional growth and development