Senior QC Engineer, CMC / GMP QA

Description

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.

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

Requirements

• Required:
• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related discipline (advanced degree preferred)
• Minimum of 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
• Additional Information
• 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.
• Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
• Mandatory Notices
• U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.
• Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
• For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
• 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.
• This position may be filled at a different job level than listed here depending on
• business need and/or on the selected candidate’s experience, knowledge and skills.
• Compensation will be based primarily on the job level at which the role is filled and the
• candidate’s qualifications, consistent with applicable law.