Senior Consultant, CMC / GMP Documentation & Quality Control

eTeam; Sunnyvale (CA); Híbrido; USD 150.000 - 230.000; Tempo integral

Resumo da vaga

eTeam is seeking a Senior Consultant, CClient / GMP Documentation & Quality Control in Sunnyvale, CA, for a 12-month engagement. The role focuses on expert review of CClient and GMP documentation with support for QC activities related to technology transfer.

The candidate will operate as a senior SME embedded within CClient and Quality teams, aiding regulatory readiness, inspection preparedness, and remediation of documentation gaps.

Qualificações

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related discipline (advanced degree preferred).
• 10+ years of experience in pharmaceutical or biotechnology CClient, GMP, or Quality roles.
• Strong hands-on experience reviewing CClient 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 CClient 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 CClient and GMP documentation is inspection-ready, accurate, and complete.
• Assist with responses to regulatory questions, inspection observations, and information requests related to CClient and QC topics.
• Review CClient 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 CClient, QA, Regulatory Affairs, and external partners.

Conhecimentos

10+ years experience

GMP documentation review

Quality Control

Regulatory readiness

Data integrity

Formação

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

Ferramentas

QMS platforms

Electronic document management systems

Descrição da vaga

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

Location: Sunnyvale, CA

Duration: 12 months

Way of Working – Remote / Hybrid

Job description

Reporting To Head of Quality Assurance

The Senior Consultant, CClient / GMP Documentation & Quality Control provides long-term, hands-on expert support primarily focused on CClient 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 CClient and Quality teams, supporting sustained development, regulatory readiness, and inspection preparedness through detailed review, quality assessment, and remediation of CClient 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 CClient 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 CClient and GMP documentation is inspection-ready, accurate, and complete
• Assist with responses to regulatory questions, inspection observations, and information requests related to CClient and QC topics
• Review CClient 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 CClient, 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 CClient, GMP, or Quality roles
• Strong hands-on experience reviewing CClient 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

Mandatory Notices

• We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
• Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
• We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.