Supplier Quality Specialist

Responsibilities

• Evaluate and qualify new suppliers and contract manufacturers through audits, risk assessments, and documentation review.
• Conduct routine supplier audits and assessments to ensure compliance with cGMP, ICH guidelines, and company quality standards.
• Collaborate with procurement and technical teams to define and monitor supplier performance metrics (KPIs, scorecards).
• Manage supplier quality agreements (SQAs) and ensure alignment with internal quality systems and regulatory expectations.
• Investigate and resolve supplier-related deviations, non-conformances, and quality issues using root cause analysis and CAPA management.
• Review and approve supplier change notifications and assess impact to product quality and regulatory filings.
• Participate in internal and external audits (e.g., FDA, MHRA) as the subject matter expert for supplier quality systems.
• Maintain supplier documentation, audit schedules, and quality records in accordance with company procedures.
• Support continuous improvement initiatives to enhance supplier quality processes and reduce quality risks.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related field.
• 3 years of experience in supplier quality, quality assurance, or auditing in the pharmaceutical, biotech, or medical device industry.
• Strong knowledge of GMP regulations (21 CFR Parts 210/211, EU GMP, ICH Q7/Q10).
• Experience conducting supplier audits and working with APIs, excipients, packaging components, or contract manufacturers.
• Excellent written and verbal communication skills.
• Strong attention to detail, organizational skills, and problem-solving ability.
• Ability

Company Overview

We are a global leader in providing integrated solutions for the pharmaceutical, biotechnology, and life sciences industries. With a strong focus on innovation, quality, and sustainability, we specialize in the development and manufacturing of drug containment and delivery systems, diagnostic components, and high-precision equipment. Our mission is to support our partners in safeguarding patient health by delivering reliable, cutting-edge technologies that meet the highest industry standards.

Operating in a highly regulated environment, we are committed to continuous improvement, operational excellence, and fostering a collaborative workplace where employees are empowered to grow and make an impact.