Senior Global Quality Assurance Manager

3 days ago

Agra, Uttar Pradesh, India beBeeSupplier Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Summary

We are seeking a highly skilled Global Quality Assurance Manager to lead our supplier quality assurance initiatives and ensure compliance with regulatory standards.

The ideal candidate will have extensive experience in managing global suppliers, developing quality strategies, and driving continuous improvement initiatives. They will be responsible for ensuring that our suppliers meet the highest standards of quality and safety.

About the Role

  • Develop and Implement Quality Strategies: Develop and implement supplier quality strategies, policies, and risk management processes to ensure compliance with regulatory requirements.
  • Lead Supplier Qualification and Approval: Lead supplier qualification, selection, and approval processes in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP).
  • Conduct Audits and Assessments: Conduct regular audits and assessments of suppliers to ensure compliance with quality and regulatory requirements.
  • Oversee CAPA and Continuous Improvement: Oversee supplier corrective and preventive actions (CAPA), root cause analysis, and continuous improvement programs to drive quality improvements.
  • Collaborate with Cross-Functional Teams: Collaborate with cross-functional teams (procurement, R&D, operations, quality) to resolve supplier-related issues and improve supply chain efficiency.

Key Responsibilities

  • Maintain Supplier KPIs: Monitor and maintain supplier key performance indicators (KPIs) such as on-time delivery, defect rates, deviations, and complaints.
  • Support New Product Development: Support new product development by ensuring supplier capability for components, raw materials, and services.
  • Manage Change Control: Manage supplier change control processes and evaluate the impact on product quality and regulatory compliance.
  • Train and Mentor Internal Teams: Train, mentor, and guide internal teams on quality systems and compliance expectations.

Requirements

  • Bachelor's/Master's Degree: Bachelor's/Master's degree in Engineering, Life Sciences, or related field.
  • 10+ Years of Experience: 10+ years of experience in supplier quality assurance, preferably in pharma/medical devices/regulated manufacturing industries.
  • Certified Lead Auditor: Certified Lead Auditor (ISO 9001/13485, GMP, or equivalent) preferred.
  • Six Sigma Certification: Six Sigma Green/Black Belt certification is a plus.

A proven track record in managing global suppliers and delivering measurable quality improvements.

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