06 set - Turbigo
ALFASIGMA
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 for strategic programs such as:
New product introductions
Network expansions
Digital quality initiatives
Build and lead a global team of quality professionals, fostering a culture of accountability and excellence.
Qualifications
Education:
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 suppliers
Skills:
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%).
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