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Director, Global Supplier and External Manufacturing Quality
Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.
Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people\'s capabilities.
But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma\'s history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.
Position Summary
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%).
Why Join Alfasigma:
At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.
Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.
Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.
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