Senior Quality Leader – GMP, Supplier & CMO Oversight

Katalyst-Healthcares-; Raritan (NJ); Presencial; USD 110 000 - 150 000; Tempo integral

Resumo da oferta

Creative Solutions Services, LLC is seeking a Senior Quality Specialist to provide GMP oversight of external manufacturers and CMOs. The role focuses on supplier qualification, audits, CAPA, deviation management, risk assessments, and change control within regulated environments.

The successful candidate will collaborate with Supply Chain, Procurement, Manufacturing, Regulatory, and Quality teams to manage supplier performance, audits, and continuous improvement initiatives.

Qualificações

• 10+ years in QA/QMS in regulated environments
• Experience with external manufacturing and CMOs
• GMP expertise
• Experience with supplier qualification and audits
• Proficient in CAPA, deviation management, and change control

Responsabilidades

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

Conhecimentos

GMP Expertise

Supplier Qualification

Audits

CAPA

Risk Assessment

Change Control

Documentation

Cross-functional Collaboration

Formação académica

Bachelor's degree in Engineering/Life Sciences

Descrição da oferta de emprego

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)