Senior Supplier Quality Specialist

4 days ago

Shimoga, Karnataka, India beBeeSupplierQuality Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Supplier Quality Professional

We are seeking a seasoned SUPPLIER QUALITY EXPERT with 10+ years of expertise in managing supplier quality assurance, development, and compliance in regulated industries.

  • Develop and Manage Supplier Strategies: Create and implement effective supplier quality strategies, policies, and risk management processes to ensure suppliers meet company, industry, and regulatory standards.
  • Lead Supplier Qualification and Approval: Oversee the qualification, selection, and approval of suppliers in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP).
  • Conduct Audits and Assessments: Conduct regular audits, assessments, and performance reviews to ensure suppliers comply with quality and regulatory requirements.
  • Manage CAPA and Continuous Improvement: Oversee supplier corrective and preventive actions, root cause analysis, and continuous improvement programs to drive quality enhancements.
  • Collaborate with Cross-Functional Teams: Work closely with procurement, R&D, operations, and quality teams to resolve supplier-related issues and ensure smooth supply chain operations.
  • Monitor Supplier Performance: Track supplier KPIs (on-time delivery, defect rates, deviations, complaints) and drive improvement initiatives to enhance supplier performance.
  • Support New Product Development: Ensure suppliers have the capability to support new product development by providing components, raw materials, and services that meet quality and regulatory requirements.
  • Manage Change Control: Oversee supplier change control processes and evaluate the impact on product quality and regulatory compliance.
  • Train and Mentor Suppliers: Train, mentor, and guide internal teams and suppliers on quality systems and compliance expectations.
  • Ensure Global Regulatory Compliance: Ensure alignment with global regulatory requirements (FDA 21 CFR Part 11/210/211, ISO standards, EU MDR, ICH guidelines).

Core Competencies and Skills:

  • Strong Expertise in Supplier Quality Management: Proven experience in supplier quality management, auditing, and regulatory compliance.
  • In-Depth Knowledge of GMP and ISO Standards: In-depth knowledge of Good Manufacturing Practices (GMP), GDP, ISO 9001, ISO 13485, and other relevant industry standards.
  • Proficiency in Risk Management: Proficiency in risk management, root cause analysis, CAPA, Six Sigma, and Lean methodologies.
  • Excellent Communication Skills: Excellent communication, negotiation, and stakeholder management skills.
  • Ability to Lead Supplier Development Programs: Ability to lead supplier development programs and strategic quality initiatives.
  • Experience in Global Supplier Management: Experience in managing global suppliers and multicultural environments.

Qualifications:

  • Bachelor's or 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.

Benefits:

  • Proven Track Record: Proven track record in managing global suppliers and delivering measurable quality improvements.

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