Global Supplier Quality Senior Specialist

Alfasigma; Milano; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A global pharmaceutical company in Milan is searching for a Global Supplier Quality Senior Specialist. The role involves managing supplier qualification and compliance activities within the supply chain, ensuring adherence to necessary regulations. Candidates should have at least 7 years of experience in supplier quality management, along with strong knowledge of GMP and ISO standards. The position offers opportunities for leadership and strategic collaboration across various functions, aiming for continuous improvement and quality excellence.

Competenze

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

Mansioni

• Lead global supplier qualification and approval processes.
• Plan and conduct supplier audits to verify compliance.
• Drive supplier performance improvement initiatives.

Conoscenze

Supplier quality management

GMP knowledge

ISO standards compliance

Risk management

Excellent communication skills

Stakeholder management

Problem-solving

Formazione

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

Strumenti

Microsoft Office Suite

Descrizione del lavoro

Global Supplier Quality Senior Specialist

Join to apply for the Global Supplier Quality Senior Specialist role at Alfasigma

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.

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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance, Research, and Science
• Pharmaceutical Manufacturing