Senior Supplier Quality Engineer at Repligen… · Marlborou…

Senior Supplier Quality Engineer

Location: Marlborough, MA

The Senior Supplier Quality Engineer is responsible for ensuring suppliers meet Repligen quality, regulatory, and technical requirements. This role partners with suppliers and internal teams to support supplier qualification, performance management, issue resolution, risk mitigation, and continuous improvement

• Supplier Qualification: Conduct technical evaluations and qualification activities for new and existing suppliers, including assessment of manufacturing processes, capabilities, quality systems, and compliance with Repligen requirements.
• Supplier Audits: Plan and conduct supplier audits, document findings, assess risk, and follow through on corrective actions and improvement opportunities.
• Supplier Quality Issues: Lead supplier-related nonconformance investigations and Supplier Corrective Action Requests (SCARs), including root cause evaluation, corrective action follow-up, and effectiveness verification.
• Supplier Change Management: Evaluate Supplier Change Notifications (SCNs), assess quality and regulatory impact, and coordinate cross-functional reviews and required actions.
• Supplier Performance: Monitor supplier quality performance and trends through scorecards, NCMRs, SCARs, audit results, and other key performance indicators. Partner with suppliers to address performance gaps.
• Supplier Risk and Development: Perform supplier risk assessments and support development plans for key and critical suppliers to reduce quality and supply risk and improve supplier capability.
• Cross-Functional Partnership: Collaborate with Quality, Sourcing, Engineering, Operations, and Regulatory teams on supplier qualification, product and process validation, supplier changes, and quality improvement activities.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline, or equivalent relevant experience.
• 7+ years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a related field.
• Experience with supplier qualification, supplier audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.
• Working knowledge of quality management systems and applicable regulatory requirements, including GMP and FDA requirements.
• Ability to evaluate manufacturing processes, technical documentation, and supplier quality systems.
• Strong problem-solving, analytical, communication, and cross-functional collaboration skills.
• Ability to travel to supplier locations as required.

Preferred Qualifications

• Experience within life sciences, biopharmaceutical manufacturing, medical devices, or another regulated industry.
• ASQ certification, Lead Auditor certification, or similar quality certification.
• Experience with statistical methods, process capability, validation, or continuous improvement tools.