Job Title: QA Specialist IV, Audits and Supplier Quality

Work Location: Harris County, Texas

Summary:

This position is responsible for leading and executing quality system audits, managing supplier quality programs, and ensuring compliance with regulatory requirements. The role involves developing audit strategies, maintaining supplier relationships, and driving continuous improvement in quality management processes.

Responsibilities:

• Lead, plan, and execute internal and external quality system audits, ensuring compliance with established procedures and regulatory standards.
• Maintain and enhance the audit program, including schedules, checklists, and comprehensive reporting of audit findings and compliance status.
• Host and support regulatory inspections, ensuring audit readiness and presenting key quality metrics to senior management.
• Oversee supplier qualification and re-qualification processes, including system assessments, on-site audits, and technical reviews to ensure robust quality management systems.
• Draft, negotiate, and maintain Supplier Quality Agreements, and monitor supplier performance through KPIs and metrics, driving performance reviews as needed.
• Lead cross-functional teams in root cause analysis and implementation of corrective and preventive actions for supplier-related quality issues.
• Conduct supplier risk assessments, manage change notifications, and coordinate change controls to mitigate supply chain risks.
• Mentor and train junior staff and cross-functional partners on audit techniques, supplier quality requirements, and quality tools, while authoring and reviewing SOPs and work instructions.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related discipline required; advanced degree preferred.
• 4+ years of progressive experience in Quality Assurance, supplier quality management, or GMP auditing within the pharmaceutical, biotechnology, or medical device industry.
• Understanding of Cell and Gene Therapies.
• Certified Quality Auditor (CQA), ISO Lead Auditor, or equivalent certification strongly preferred.
• Experience hosting and supporting FDA, EMA, MHRA, or other regulatory inspections.
• Familiarity with Health Authority regulations (US FDA, EMA, ISO 9001, ISO 13485, etc.) preferred.
• Understanding of GxPs and advanced knowledge of supplier qualification, auditing principles, and risk management tools.
• Knowledge of local and global regulations.
• Excellent verbal and written communication, interpersonal, and customer service skills.
• Strong organizational skills, attention to detail, and time management abilities with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Proficiency with Microsoft Office Suite or related software.

Published Category: Quality & Validation