Codexis, Inc. · 16 hours ago
Director of Quality and Compliance
Redwood City, CA
Full-time
Onsite
Director/Executive
$225K/yr - $250K/yr
12+ years expCodexis, a biotechnology company based in Redwood City, CA, is looking to hire a Director of Quality and Compliance. This role will provide leadership, strategy, and oversight for the company’s Quality Management System to ensure alignment with regulatory expectations and drive continuous improvement in quality processes.
BiotechnologyChemicalSustainability
Responsibilities
Lead the development, implementation, and continuous improvement of the corporate Quality Management System
Own core GxP quality systems including: Deviations / investigations, CAPA, Change control, Document control, Training, Supplier quality, Internal audits and risk management
Ensure ongoing compliance with FDA, EU, and ICH guidelines as well as ISO 9001 expectations
Lead preparation for regulatory inspections, partner audits, and customer quality assessments
Host audits and coordinate timely, effective resolution of findings
Conduct internal and external audits
Establish compliance KPIs, management reviews, and quality dashboards
Partner with QA, QC, Manufacturing, Process Development, Analytical Development, Regulatory, and Supply Chain to ensure cross‑functional compliance
Ensure training programs meet compliance requirements and role‑based proficiency expectations
Oversee document lifecycle management, ensuring documentation accuracy, traceability, and version control
Lead QRM programs using ICH Q9 principles
Ensure processes are risk‑based, controlled, and continually improved
Oversee supplier qualification, ongoing monitoring, and quality technical agreements
Ensure CMOs meet required GMP, compliance, and documentation standards
Drive structured, risk‑based change control ensuring sustained compliance with manufacturing and facility changes, tech transfers, and process modifications
Ensure ALCOA+ principles are embedded in operations
Partner with IT/Automation to maintain validated systems where required
Qualification
Required
BS/BA in a scientific discipline (chemistry, biology, engineering); advanced degree preferred
12+ years pharmaceutical or biotech Quality experience with significant exposure to QA/QC operations, regulatory inspections, and quality systems management
Deep understanding of GMP, ICH guidelines, 21 CFR 210/211, and ISO 9001
Demonstrated success leading internal and external audits
Experience building or maturing a quality system in a growing organization
Experience in implementation of eQMS Systems
Expert Knowledge in Facilities, Utilities, Equipment and Process Validations
Preferred
Experience commissioning facilities
Experience supporting or leading GMP facility readiness
Experience with CDMOs and supplier quality oversight
Experience with RNA, biologics, enzyme engineering, or advanced manufacturing technologies
Experience integrating quality in tech transfer or scale‑up environments
Technical experience or understanding in fermentation/DSP and quality control
Previous responsibility for assessing whether products meet specifications, required quality standards and determining disposition of products
Previous experience building efficient quality systems
Benefits
Medical, Dental and Vision Insurance
Basic Life, AD&D, Short- and Long-Term Disability Insurance
401k with Company Match up to 4%
Company Equity
Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time
Annual Lifestyle Account for reimbursement of fitness programs, equipment and more
Employee Stock Purchase Program (ESPP)
Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare)
Student Debt Program (Company Contribution to Loans)
Mental Health Wellness Program
Subsidized onsite lunch program
Onsite Gym Facilities
Paid Parental Leave
And More!
Company
Codexis, Inc.
Codexis is redefining what is possible in therapeutic development and manufacturing, leading the technology revolution with efficient, high-quality, and commercially proven solutions.
51-200 employees
H1B Sponsorship
Codexis, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (9)
2022 (4)
Funding
Current Stage
Public CompanyTotal Funding
$219.3MKey Investors
Innovatus Capital PartnersCasdin CapitalEDBI
2025-08-13Post Ipo Equity· $27.3M
2025-08-13Post Ipo Debt
2024-02-13Post Ipo Debt· $30M
Leadership Team
Georgia Erbez
Chief Financial Officer and Chief Business Officer
Recent News
2026-01-08
Company data provided by crunchbase