Senior CMC & GMP Documentation Consultant

Integrated Resources, Inc.; United States; Presencial; USD 138.000 - 204.000; Tempo integral

Resumo da vaga

Integrated Resources, Inc (IRI) in Sunnyvale, CA seeks a Senior CMC Consultant focused on GMP documentation and quality control. The role delivers long-term, hands-on support for CMC and GMP documentation, with QC assistance tied to technology transfer, for an early- to late-stage pharmaceutical organization.

The senior specialist operates within CMC and Quality teams to drive regulatory readiness, inspection preparedness, and remediation of documentation.

Qualificações

• 10+ years of experience in pharmaceutical or biotechnology CMC, GMP, or Quality roles
• Strong hands-on experience reviewing CMC and GMP documentation
• Working knowledge of GMP requirements for drug substance and drug product development
• Experience supporting QC documentation, investigations, and data integrity requirements

Responsabilidades

• Perform detailed quality review of CMC documentation including specifications, batch records, validation documentation, stability protocols and reports, and technical reports
• Review GMP documentation for compliance with FDA, EMA, ICH, and other applicable global regulatory requirements
• Identify documentation gaps, inconsistencies, and compliance risks and recommend corrective actions
• Support QC documentation review activities related to analytical methods, test records, and data packages
• Provide QC documentation and quality review support for technology transfer activities, as needed
• Support investigations related to QC deviations, OOS/OOT results, and documentation discrepancies
• Support inspection readiness by ensuring CMC and GMP documentation is inspection-ready, accurate, and complete
• Assist with responses to regulatory questions, inspection observations, and information requests related to CMC and QC topics
• Review CMC and GMP documentation generated by CDMOs, testing laboratories, and other external partners
• Provide clear, practical documentation feedback to vendors to drive compliance and quality improvements
• Collaborate closely with CMC, QA, Regulatory Affairs, and external partners

Conhecimentos

CMC documentation review

GMP knowledge

Documentation quality review

Regulatory readiness

Inspection preparation

Formação

Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related discipline

Ferramentas

Electronic document management systems

QMS platforms

Descrição da vaga

Integrated Resources, Inc (IRI) in Sunnyvale, CA seeks a Senior CMC Consultant focused on GMP documentation and quality control. The role delivers long-term, hands-on support for CMC and GMP documentation, with QC assistance tied to technology transfer, for an early- to late-stage pharmaceutical organization.

The senior specialist operates within CMC and Quality teams to drive regulatory readiness, inspection preparedness, and remediation of documentation.