Senior Supplier Quality Engineer: Drive Supplier Excellence

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

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.