Supplier QA Manager

Responsibilities

• Ensure that all raw materials, components, and outsourced services meet company, regulatory, and GMP requirements.
• Evaluate and approve new and existing suppliers through audits, qualification programs, and performance monitoring.
• Lead supplier audits and inspections, including preparation, execution, reporting, and follow-up on corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams including Procurement, Operations, R&D, and Regulatory Affairs to address supplier quality issues and implement corrective actions.
• Manage supplier risk assessments, track supplier performance metrics, and identify opportunities for continuous improvement.
• Oversee documentation related to supplier qualification, audit findings, CAPAs, and regulatory compliance.
• Provide leadership and guidance to a team of quality assurance professionals responsible for supplier management activities.
• Serve as the primary point of contact for supplier quality matters during internal, external, and regulatory inspections.
• Ensure adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and company quality standards.
• Support cross-functional projects involving supplier changes, new product launches, or compliance initiatives.

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field. Advanced degree preferred.
• 7+ years of experience in quality assurance within the pharmaceutical, biotechnology, or related regulated industry, with at least 3 years in supplier quality management.
• Proven experience in supplier auditing, risk management, CAPA systems, and GMP-compliant documentation.
• Strong knowledge of FDA, EMA, ICH, and other global regulatory requirements related to supplier qualification and management.
• Excellent leadership, communication, and interpersonal skills, with the ability to manage multiple priorities in a fast-paced environment.
• Experience working with automated quality systems, ERP software, or supplier management tools.
• Certified Quality Auditor (CQA) or equivalent certification.
• Lean Six Sigma or other process improvement training.
• Knowledge of validation principles, supply chain operations, and regulatory inspections.