Supplier Quality Assurance

Supplier Quality Management Specialist- Somerset NJ

Reports to: Regulatory and Compliance Manager

Full benefits position, PTO (paid holidays, sick, vacation days, floating etc.), 401k match

Summary of Essential Functions:

This position is responsible for ensuring the quality of products sourced from external suppliers by overseeing supplier assessments, audits, and supplier performance management. The role involves ensuring compliance with all relevant regulatory standards (such as cGMP), implementing corrective action plans (CAPAs), driving continuous improvement initiatives, and collaborating with internal teams, including procurement and manufacturing, to maintain product quality throughout the supply chain.

• Supplier Quality Management – Experience in managing supplier relationships, conducting audits, supplier qualification, and performance monitoring.
• cGMP Knowledge – Understanding of current Good Manufacturing Practices (cGMP) regulations and how they apply to the pharmaceutical industry, ensuring compliance across the supply chain.
• Audit and Compliance – Ability to conduct supplier audits, assess quality systems, and ensure adherence to regulatory standards (e.g., FDA, ICH).
• Data Analysis – Strong analytical skills to interpret complex data, identify trends, and solve quality-related issues effectively using quality tools and statistical analysis.
• Corrective Action and Continuous Improvement – Experience in implementing Corrective Action Plans (CAPAs) and driving continuous improvement initiatives to resolve quality issues and enhance supplier performance.
• Technical Writing and Documentation – Proficiency in reviewing and managing technical quality agreements (TQAs), supplier documentation, and ensuring all records are in compliance with regulatory requirements.
• Cross-functional Collaboration – Strong communication and interpersonal skills to work effectively with internal teams (e.g., procurement, manufacturing, quality assurance, and product development) and external suppliers.
• Supplier Performance Reviews – Ability to assess and provide feedback on supplier performance, track supplier quality metrics, and ensure corrective actions are implemented.
• Change Control Management – Experience in reviewing and approving supplier change controls, ensuring that changes do not negatively affect product quality.

Education and Experience:

• Bachelor’s degree required, preferably in a pharmaceutical or technical field. 3 years of experience in pharmaceutical/biological manufacturing, packaging, and laboratory operations. Extensive knowledge of cGMP regulations and quality principles within the pharmaceutical industry. Proven experience in supplier quality management, including conducting supplier audits, supplier qualification, and performance monitoring.