Supplier Quality Associate

Role Summary

The Supplier Quality Associate is a critical role responsible for overseeing the development and maintenance of a robust supplier quality program, managing external audit programs, and ensuring GMP compliance. This position drives supplier qualifications, conducts risk-based audits, and collaborates with cross-functional teams to maintain high-quality standards and support continuous improvement. The ideal candidate is detail-oriented with extensive experience in supplier quality management and GMP/GLP environments, capable of working independently to meet project goals while ensuring regulatory compliance.

Responsibilities

• Develop and Maintain Supplier Quality Program: Create, implement, and sustain a comprehensive supplier quality program to ensure consistent quality across the supply chain
• Travel: Occasional travel may be required for supplier audits or vendor meetings
• Create Supplier Scorecards: Develop and maintain scorecards to evaluate supplier performance and drive accountability
• Ensure Audit Readiness: Maintain audit readiness and compliance with GMP and other regulatory standards
• Conduct Supplier Qualifications and Audits: Perform supplier qualifications and risk-based audits to ensure supplier compliance and quality
• Manage SCAR Activities: Oversee all supplier corrective action processes, ensuring timely resolution of issues
• Collaborate on Material Specifications: Work with cross-departmental teams to develop and refine material specifications
• Prepare Quality Metrics: Compile and present quality metrics to stakeholders to support decision-making
• Address Quality Issues: Partner with internal teams to resolve supplier quality and audit-related challenges
• Drive Best Practices: Contribute to the development and implementation of best practices to enhance compliance and performance
• Perform Data Analysis: Conduct data analysis and maintain organized records, reports, and databases to support quality processes
• Implement Continuous Improvement: Recommend and implement measures to enhance quality processes and operational efficiency
• Present Data Internally: Deliver data-driven insights to support decision-making and quality initiatives
• Work Independently: Operate with minimal supervision to achieve project goals and meet deadlines
• Review and Approve Documents: Review and approve assigned documents to ensure accuracy and compliance
• Perform Additional Duties: Undertake other quality-related responsibilities as assigned to support organizational objectives

Qualifications

• Education: Bachelor’s degree in a relevant Biological Science discipline required
• Experience: 3 years of experience in a GMP Quality Control laboratory or GMP/GLP setting required, with direct experience in Supplier Quality Management and corporate/supplier audits
• Experience conducting audits is a plus
• Supplier/Vendor Qualification: 3+ years of hands-on experience in qualifying suppliers and vendors, including risk assessments, capability evaluations, and ongoing performance monitoring
• SCAR Management: Experience managing Supplier Corrective Action Requests (SCARs), from initiation through closure, ensuring timely and effective resolution of quality issues
• SOP Development: Skilled in drafting, revising, and maintaining SOPs to support quality system effectiveness and regulatory compliance
• Experience facilitating Supplier Quality Agreements is a plus
• Technical Skills: Proficiency in Outlook, MS Office, and eQMS is a plus
• Communication and Teamwork: Excellent communication, time-management, and teamwork skills to collaborate effectively across departments
• Organizational Skills: Strong organizational skills and attention to detail to manage records, reports, and databases
• Multitasking: Ability to prioritize and manage multiple responsibilities in a fast-paced environment
• Work Environment Adaptability: Ability to gown and work in classified areas for audits or inspections
• Independent Work: Ability to independently perform tasks, generate reports, and escalate issues as needed
• ASQ CQA certification preferred; candidates without current certification must demonstrate a willingness and ability to obtain certification within a specified timeframe
• Strong team player with the ability to collaborate effectively across cross-functional departments

Education

• Bachelor’s degree in a relevant Biological Science discipline

Additional Requirements

• Travel: Occasional travel may be required for supplier audits or vendor meetings
• Work Environment and Physical Demands: Setting primarily office- and laboratory-based; gowning in classified areas; prolonged computer use; occasional lifting up to 20 pounds