Quality Control Analyst 

Job Description

Job Summary:

• 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.

Duties 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.

Required Qualifications:

• 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:

• 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.