CMC / GMP Documentation & Quality Control Consultant

Rang Technologies Inc; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

Rang Technologies Inc. in Sunnyvale, CA, is seeking a Senior Consultant to provide long-term, hands-on support focused on CMC and GMP documentation review, with additional QC support related to technology transfer.

The role is embedded within CMC and Quality teams to help maintain regulatory readiness and inspection preparedness. This consulting position has no people-management responsibilities and offers remote work options.

Qualifications

• 10+ years of 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 product development.
• Experience supporting QC documentation, investigations, and data integrity requirements.

Responsibilities

• 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.

Job description

Job Title: Senior Consultant, CMC / GMP Documentation & Quality Control

Location: Sunnyvale, CA - Remote

Duration: 12 Months

The Senior Consultant, CMC / GMP Documentation & Quality Control provides long-term, hands‑on expert support primarily focused on CMC and GMP documentation review, with additional support for Quality Control (QC) activities related to technology transfer, for an early‑to‑late‑stage pharmaceutical development organization.

This role serves as a senior subject matter expert embedded within CMC and Quality teams, supporting sustained development, regulatory readiness, and inspection preparedness through detailed review, quality assessment, and remediation of CMC and GMP documentation. QC support is primarily documentation‑ and review‑focused, with limited hands‑on involvement in technical transfer activities as needed. This is a long‑term consulting role with no people‑management responsibilities.

Key Responsibilities

• 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

Qualifications

Required:

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related discipline (advanced degree preferred)
• 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

Preferred:

• Experience supporting early‑stage through late‑stage development programs
• Experience working with CDMOs and external testing laboratories
• Experience supporting technology transfer documentation or QC readiness activities
• Experience supporting regulatory inspections or agency interactions
• Familiarity with electronic document management systems and QMS platforms

“We are an equal opportunity employer. It is our policy to provide employment, compensation, and other benefits related to employment without regard to race, color, religion, sex, gender, national or ethnic origin, disability, veteran status, age, genetic information, citizenship, or any other basis prohibited by applicable federal, state, or local law.”