Chemistry, Manufacturing & Controls (CMC) - P3

Job Title: Senior Consultant, CMC / GMP Documentation & Quality Control Pay rate- up to $148.14/h for Visa Independent candidate

Salary- for Visa dependent candidate- up to $286799

Ideal-4 days in week onsite at Sunnyvale, CA, open to remote also Remote candidate will need to travel to be onsite 1-2 timesin qurter Location - Sunnyvale, CA

Way of Working – Remote / Hybrid

Reporting To - Head of Quality Assurance

Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

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

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.