Validation Engineer

hace 1 semana

Barcelona, Barcelona, España EPM Scientific A tiempo completo

Job Title:
Supplier Quality Manager

About the Role:

We are looking for an experienced
Supplier Quality Manager
to lead supplier quality activities within our pharmaceutical operations. This role is essential to ensuring that all raw materials, components, and services provided by suppliers meet strict
GMP (Good Manufacturing Practices)
and regulatory standards. The ideal candidate will have strong leadership skills, deep knowledge of pharmaceutical quality systems, and experience managing supplier relationships in a highly regulated environment.

Key Responsibilities:

  • Strategic Leadership:

  • Define and implement the supplier quality strategy in alignment with corporate objectives and
    EU GMP
    requirements.

  • Lead and develop a team of Supplier Quality Engineers and specialists.

  • Supplier Qualification & Oversight:

  • Manage supplier qualification, auditing, and monitoring programs to ensure compliance with
    EMA
    ,
    ICH Q7/Q10
    , and other relevant guidelines.

  • Approve and maintain supplier quality agreements.

  • Risk Management & Continuous Improvement:

  • Conduct supplier risk assessments and implement mitigation plans.

  • Drive continuous improvement initiatives across the supply base to enhance quality and reliability.

  • Cross-Functional Collaboration:

  • Work closely with Procurement, Manufacturing, and Regulatory Affairs to support new product launches and supplier integration projects.

  • Act as the escalation point for critical supplier quality issues.

  • Governance & Reporting:

  • Develop and monitor supplier KPIs and quality metrics, reporting to senior management.

  • Ensure timely resolution of deviations, non-conformances, and CAPAs.

Qualifications:

  • Experience:
  • 10+ years in Quality Assurance or Supplier Quality within the pharmaceutical industry, with at least 5 years in a leadership role.
  • Certifications:
  • Lead Auditor certification (ISO 9001, EU GMP, or equivalent).
  • Skills:
  • Strong knowledge of
    EU GMP
    ,
    ICH guidelines
    , and regulatory requirements for pharmaceutical suppliers.
  • Proven ability to lead teams and manage complex supplier relationships.
  • Excellent communication and negotiation skills.

Additional Skills:

  • Strategic mindset with strong analytical and organizational capabilities.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Proficiency in Quality Management Systems (QMS) and supplier quality tools.

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