ISIJP00012528 Senior Consultant, CMC / GMP Documentation & Quality Control not avail for ref

Job Title: Senior Consultant, CMC / GMP Documentation & Quality Control
Location - Sunnyvale, CA - Prefer Onsite but for Highly qualified candidate Remote can be option.
Reporting To - Head of Quality Assurance

Job 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.

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

Requirements

CORRECTION:

Spotlight Call Notes: Intuitive Surgical Req#ISIJP00012528 Senior Consultant, CMC / GMP Documentation & Quality Control

HM: Leslie White

Pay Rate: $148/HR W2

Locations: Sunnyvale, CA (Prefer Onsite 4 days per week) / Remote for highly qualified candidate (option) but they have to travel onsite Sunnyvale Approximately once per quarter or less, with possible additional travel for exceptional events such as an audit.

Project Duration: 12 Months

No of Position: 1 Positions

Interview Process: Zoom 2 or 3 Rounds

First know what’s the project about: Support Intuitive's small-molecule drug programs as they move toward U.S. NDA (New Drug Application) submissions, with an additional outside-U.S. regulatory strategy.

Current need: The team needs a senior quality professional to retrospectively review existing chemistry and analytical documentation, verify that reported results are supported by underlying data, and identify quality gaps.

Workload over the next six months: Approximately 50–60 analytical reports, at least as many analytical batch records, and 10+ method-transfer reports.

Why they need this person: To ensure the existing analytical work and documentation are scientifically sound, GMP-compliant, and appropriate for the drug development stage.

Nature of the role: Primarily hands-on technical documentation review, with some support for analytical method transfer and possible remediation of identified issues.

Top 4 skills the Hiring Manager wants:

GMP documentation review: Must have personally reviewed pharmaceutical quality documentation, analytical reports, batch records, and underlying data. Document coordination or writing alone is not enough.

Small-molecule analytical chemistry: Must understand small-molecule chemistry, organic chemistry, and analytical methods. Biologics-only candidates are generally not suitable.

Statistical analysis and process controls: Must be able to critically evaluate analytical results and understand statistical process controls, rather than simply check documents for completeness.

Drug development lifecycle knowledge: Must understand how analytical methods and documentation requirements change with the development stage, including retrospective review and readiness for Phase 3/NDA work.

Non-negotiable skills

· Proven, hands-on GMP analytical documentation review experience.

· Strong small-molecule pharmaceutical or analytical chemistry knowledge.

· Ability to assess analytical data and determine whether reported results are supported by the underlying evidence.

· Understanding of statistical reasoning and statistical process controls.

· Knowledge of drug development stages and phase-appropriate analytical documentation.

· Ability to work independently within established quality systems and SOPs.

Technical skills and tools

· Analytical methods: HPLC, Karl Fischer, mass spectrometry, USP-style methods, and balance-related analytical work.

· Quality systems: General QMS experience is required.

· IQVIA SmartSolve: Used by Intuitive, but prior experience with this specific platform is not required.

· SOPs: Must be comfortable following established SOPs and completing required training.

· LIMS: No specific LIMS experience is needed for this role.

· Preferred, not mandatory: CDMO pre-approval audit preparation, Module 3 regulatory writing, and broader regulatory interaction experience.