Senior CMC/GMP Documentation QC Consultant

Intuitive; Sunnyvale (CA); Presencial; USD 159.000 - 187.000; Tempo integral

Resumo da vaga

Intuitive is seeking a Senior Consultant, CMC / GMP Documentation & Quality Control to provide long-term, hands-on expert support focused on CMC and GMP documentation review, with additional QC activities related to technology transfer for an early- to late-stage pharmaceutical development program.

In this role you will review specifications, batch records, validation and stability documents, support QC investigations, and help ensure inspection readiness while collaborating with CMC, QA,

Qualificações

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related discipline (advanced degree preferred).
• Minimum of 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 applicable to drug substance and drug product development.
• Experience supporting QC documentation, investigations, and data integrity requirements.
• Demonstrated ability to identify documentation gaps and drive corrective actions.

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 review

GMP documentation

Quality control

Regulatory liaison

Cross-functional collaboration

Formação

Bachelor’s degree in Chemistry, Engineering, Life Sciences

Ferramentas

QMS platforms

Electronic Document Management Systems (EDMS)

Descrição da vaga

Intuitive is seeking a Senior Consultant, CMC / GMP Documentation & Quality Control to provide long-term, hands-on expert support focused on CMC and GMP documentation review, with additional QC activities related to technology transfer for an early- to late-stage pharmaceutical development program.

In this role you will review specifications, batch records, validation and stability documents, support QC investigations, and help ensure inspection readiness while collaborating with CMC, QA,