CMC Senior Consultant Quality Assurance

Integrated Resources, Inc.; Sunnyvale (CA); Presencial; USD 150.000 - 190.000; Tempo integral

Resumo da vaga

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,

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

CMC documentation review

GMP documentation review

Quality control documentation

Regulatory readiness

Formação

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

Advanced degree preferred

Ferramentas

Electronic document management systems

QMS platforms

Descrição da vaga

• 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.