Senior CMC/GMP QA Consultant — Documentation & QC

Integrated Resources, Inc.; Sunnyvale (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Integrated Resources, Inc seeks a Senior Consultant focused on CMC/GMP documentation and quality control. The role embeds within CMC and Quality teams to support regulatory readiness and inspection preparedness through meticulous review, quality assessment, and remediation of CMC and GMP documentation.

QC documentation review is primary, with limited involvement in transfer activities. This is a long-term consulting role without people-management responsibilities, collaborating with QA,

Qualifications

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related discipline (advanced degree preferred).
• 10+ years of experience in pharmaceutical/biotech CMC, GMP, or Quality roles.
• Strong hands-on experience reviewing CMC and GMP documentation.
• Familiarity with GMP requirements for drug substance and drug product development.

Responsibilities

• Perform detailed quality review of CMC documentation including specs, batch records, validation docs, stability protocols and reports.
• Review GMP documentation for compliance with FDA, EMA, ICH and global regulatory requirements.
• Identify documentation gaps and compliance risks; recommend corrective actions.
• Support QC documentation review for analytical methods, test records, and data packages.
• Provide QC documentation and quality review support for technology transfer activities.
• Assist with responses to regulatory questions and inspection observations related to CMC and QC.
• Review CMC and GMP documentation generated by CDMOs, testing labs, and external partners.

Skills

CMC documentation review

GMP documentation review

Quality control documentation

Regulatory readiness

Education

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

Advanced degree preferred

Tools

Electronic document management systems

QMS platforms

Job description

Integrated Resources, Inc seeks a Senior Consultant focused on CMC/GMP documentation and quality control. The role embeds within CMC and Quality teams to support regulatory readiness and inspection preparedness through meticulous review, quality assessment, and remediation of CMC and GMP documentation.

QC documentation review is primary, with limited involvement in transfer activities. This is a long-term consulting role without people-management responsibilities, collaborating with QA,