Senior Quality Leader – GMP, Supplier & CMO Oversight

Creative Solutions Services, LLC; Raritan (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

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.

Qualifications

• 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

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 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

Skills

GMP Expertise

Supplier Qualification

Audits

CAPA

Risk Assessment

Change Control

Documentation

Cross-functional Collaboration

Education

Bachelor's degree in Engineering/Life Sciences

Job description

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.