Global Supplier Quality Senior Specialist

2 giorni fa

Milano, Lombardia, Italia Alfasigma A tempo pieno

Job description:

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

Supplier Qualification & Management

  • 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.

Qualifications

  • 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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