Senior Quality Specialist

Katalyst CRO; Raritan (NJ); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO in New Jersey is seeking a Senior Quality Specialist with 10+ years of QA/Quality Systems experience in regulated environments. You will oversee external manufacturing, CMOs, supplier qualification, audits, CAPA, change control, risk assessments, and QA documentation while collaborating with Supply Chain, Manufacturing, Regulatory, and Quality teams.

Strong GMP expertise and a proven track record in supplier management and continuous improvement are required to ensure compliance and

Qualifications

• Bachelor's degree in engineering, Life Sciences, Natural Sciences, or related field.
• 10+ years of Quality Assurance and/or Quality Systems experience in regulated environments.
• Experience supporting External Manufacturing and CMOs.
• GMP expertise.
• Supplier qualification and supplier management experience.
• Audit planning, execution, reporting, and CAPA follow-up.
• Deviation investigation and CAPA management experience.
• Risk assessment experience.
• Technical Agreements and Quality Documentation experience.
• Change Control Management experience.
• Strong cross-functional collaboration with Supply Chain, Procurement, and Manufacturing teams.
• Quality Systems experience (GMP, ISO, HACCP).

Responsibilities

• Provide Quality oversight for External Manufacturing, CMOs, and third-party manufacturers to ensure GMP compliance and quality standards.
• Manage supplier qualification, approval, monitoring, and ongoing performance through risk-based assessments, audits, metrics, and CAPA.
• Plan, coordinate, and execute supplier/CMO audits, including prep, execution, reporting, observations, and CAPA closure.
• Lead deviation investigations, root cause analysis, CAPA development, implementation, and effectiveness checks.
• Perform quality risk assessments related to suppliers, manufacturing processes, materials, changes, deviations, and quality events.
• Develop, review, and maintain Technical Agreements, Quality Agreements, SOPs, specifications, and GMP quality documentation.

Skills

Quality Assurance

Quality Systems

GMP

Audits

CAPA

Risk assessment

Change control

Supplier management

Education

Bachelor's degree in engineering or Life Sciences

Job description

Summary

We are seeking a Senior Quality Specialist with 10+ years of experience in Quality Assurance and Quality Systems within regulated environments. The ideal candidate will have strong expertise in GMP, supplier quality, external/contract manufacturing, CMO oversight, audits, CAPA, deviation management, risk assessment, and change control. This role will provide Quality oversight of suppliers and third-party manufacturers while ensuring compliance with applicable Quality Management Systems and regulatory requirements. The candidate will collaborate closely with Supply Chain, Procurement, Manufacturing, Regulatory, and Quality teams to manage supplier performance, quality issues, audits, technical agreements, and continuous improvement initiatives.

Roles & Responsibilities

• Provide Quality oversight for External Manufacturing, Contract Manufacturing Organizations (CMOs), and third-party manufacturers to ensure compliance with GMP, Quality Agreements, and company quality standards.
• Manage supplier qualification, approval, monitoring, and ongoing supplier performance through risk-based assessments, audits, quality metrics, and corrective actions.
• Plan, coordinate, and execute supplier/CMO audits, including audit preparation, execution, reporting, observations, and CAPA follow-up to closure.
• Lead and support deviation investigations, root cause analysis, CAPA development, implementation, and effectiveness checks.
• Perform quality risk assessments related to suppliers, manufacturing processes, materials, changes, deviations, and quality events.
• Develop, review, and maintain Technical Agreements, Quality Agreements, SOPs, specifications, and other GMP quality documentation.

Education & Experience

• Bachelor's degree in engineering, Life Sciences, Natural Sciences, or related field
• 10+ years of Quality Assurance and/or Quality Systems experience in regulated environments
• Experience supporting External Manufacturing and Contract Manufacturing Organizations (CMOs)
• GMP/Good Manufacturing Practices expertise
• Supplier Qualification and Supplier Management experience
• Audit Planning, Execution, Reporting, and CAPA Follow-Up
• Deviation Investigation and CAPA Management experience
• Risk Assessment experience
• Technical Agreements and Quality Documentation experience
• Change Control Management experience
• Strong cross-functional collaboration with Supply Chain, Procurement, and Manufacturing teams
• Quality Systems experience (GMP, ISO, HACCP)