Senior Supplier Quality Engineer

Repligen Corp; Marlborough (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Repligen Corp is seeking a seasoned Supplier Qualification professional to lead qualification activities, supplier audits, and CAPA/SCAR processes. You will coordinate cross-functional reviews and monitor supplier performance to mitigate risk within a regulated bioprocessing environment.

Ideal candidates hold a technical degree with 7+ years in supplier quality and possess GMP/FDA knowledge and travel flexibility to supplier sites as required.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related discipline; 7+ years in supplier quality or related field.
• Experience with supplier qualification, audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.
• Knowledge of GMP and FDA regulatory requirements; able to travel to supplier locations.

Responsibilities

• Plan and conduct supplier qualification activities evaluating processes and quality systems.
• Perform supplier audits and document findings; assess risk and drive corrective actions.
• Lead investigations into supplier nonconformances and SCAR processes with root cause analysis.
• Evaluate supplier change notifications and coordinate cross-functional reviews.
• Monitor supplier quality performance via scorecards, NCMRs, SCARs, audits.
• Support development plans for key suppliers to reduce risk and improve capability.
• Collaborate with Quality, Sourcing, Engineering, Operations, and Regulatory teams.

Skills

Supplier Quality

Audits

CAPA/SCAR

Root cause analysis

GMP/FDA knowledge

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or related discipline

Job description

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.

Thank you for your interest in Repligen! Working at Repligen means being part of a team that is excited to find new and creative ways to overcome challenges in bioprocessing — and to help our customers make a difference in the world.