CMC, GMP & Quality Assurances Consultant

Position Summary

The QA Contractor will provide Quality Assurance oversight of outsourced CMC activities performed by CROs, and analytical laboratories. The role is responsible for ensuring that all CMC activities and deliverables comply with applicable GMP, ICH, FDA/EMA, and company quality requirements.

Key Responsibilities

• Provide QA oversight of outsourced CMC activities and external service providers.

• Review and approve CMC-related documents, including protocols, reports, batch records, specifications, deviations, CAPAs, change controls, and validation documentation.

• Review quality events, investigations, and risk assessments, ensuring timely resolution.

• Support vendor qualification, audits, and ongoing quality performance.

• Support CMC regulatory submissions and inspection readiness.

• Identify quality risks and provide QA guidance to cross-functional teams.

Qualifications

• Degree in a scientific discipline.

• 5–8 years of pharmaceutical QA experience with CMC.

• Strong knowledge of GMP, ICH guidelines, and outsourced quality oversight.

• Excellent technical review, communication, and organizational skills.