Global Supplier Quality Senior Specialist - Bologna - Alfasigma S.p.A.

    Alfasigma S.p.A.
    Alfasigma S.p.A. Bologna

    3 ore fa

    Descrizione

    Global Supplier Quality Senior Specialist


    About Us


    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 in Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubling 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 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.

    As we continue to grow, we are seeking a Global Supplier Quality Senior Specialist, to join our Global Quality team and help shaping our continued success

    Position Overview


    The Senior Specialist, Global Supplier Quality is responsible for driving supplier qualification, monitoring, and compliance activities across the global supply chain. This role plays a critical part in ensuring that all suppliers of raw materials, components, and services consistently meet regulatory, quality, and safety requirements.

    Acting as a key interface between internal stakeholders and external suppliers, the Senior Specialist will champion quality excellence, risk mitigation, and continuous improvement to strengthen the company's global quality network and ensure business continuity.

    Key Responsibilities

    • Lead global supplier qualification, approval, and requalification processes in alignment with corporate and regulatory standards.
    • Develop and maintain comprehensive supplier risk assessments and qualification documentation.
    • Oversee the full supplier lifecycle — from onboarding and performance monitoring to periodic reviews and requalification.

    Audits & Compliance


    Plan, conduct, and report supplier audits (both on-site and remote) to verify compliance with internal and external standards.

    Ensure adherence to GMP, ISO 13485, HACCP, and other applicable global quality and regulatory frameworks.

    Partner with suppliers to address audit findings, implement corrective and preventive actions, and monitor their effectiveness.

    Documentation & Quality Systems


    Support site quality operations in reviewing and approving supplier-provided documentation, including change controls, technical files, and periodic reviews.

    Maintain and update Supplier Quality Agreements, ensuring alignment with internal policies and regulatory requirements.

    Contribute to the preparation and successful execution of regulatory inspections and customer audits related to supplier management.

    Risk Management & Continuous Improvement


    Proactively identify and mitigate supplier-related risks impacting product quality or supply continuity.

    Drive supplier performance improvement initiatives to enhance quality, reliability, and compliance maturity.

    Monitor supplier KPIs, conduct performance reviews, and promote a culture of continuous improvement.

    Cross-Functional Collaboration


    Collaborate closely with Procurement, Manufacturing, R&D, and Regulatory Affairs to ensure alignment on supplier quality strategy and standards.

    Provide expert guidance, training, and support to internal teams on supplier qualification, compliance, and audit processes.

    Qualification


    Minimum 7 years' experience in supplier quality management within pharmaceuticals, medical devices, or food supplements.

    Strong working knowledge of GMP, ISO 13485, HACCP, and global regulatory expectations.

    Demonstrated success in supplier audits, risk-based quality management, and compliance oversight.

    Lead Auditor certification highly desirable.

    Bachelor's or Master's degree in Pharmacy, Chemistry, Engineering, or a related technical field.

    Proven experience using digital tools and systems for supplier qualification and performance management.

    Exceptional communication, stakeholder management, and problem-solving skills.

    Ability to operate effectively in a fast-paced, matrixed, and multicultural environment.

    Fluency in English required; additional languages are a plus.

    Strong proficiency with Microsoft Office Suite and other business platforms.

    Strategic, analytical, and results-oriented mindset with a commitment to quality excellence.


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