Director of Quality and Compliance
Codexis, Inc., Redwood City, California, United States, 94061
Director of Quality and Compliance
Department:
57 - Quality Assurance
Employment Type:
Full Time
Location:
Redwood City, CA
Compensation:
$225,000 - $250,000 / year
Description Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a
Director of Quality and Compliance.
Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins. Codexis enzymes solve real-world challenges associated with small molecule pharmaceuticals manufacturing and nucleic acid synthesis. The Company is currently developing its proprietary ECO Synthesis™ platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route. Codexis enzymes can drive improvements, such as higher yields, reduced energy usage and waste generation, improve efficiency in manufacturing and greater sensitivity in genomic and diagnostic applications.
To meet the goals we’ve set for ourselves, we look for individuals who are driven, eager to grow and ready to embrace meaningful challenges. We empower employees to be authentic, ambitious, and agile and have the courage to act where they can make a positive impact.
Come join us on this journey to transform the enzyme engineering landscape for the betterment of human health.
About the Opportunity The Director of Quality and Compliance will provide leadership, strategy, and oversight for the company’s Quality Management System (QMS) to ensure alignment with regulatory expectations (FDA, EMA, ICH, ISO 9001, 21 CFR 210/211).
This role builds and maintains compliant quality systems, drives inspection readiness, ensures continuous improvement, and partners cross‑functionally to embed a culture of quality throughout asset development and manufacturing operations.
The Director will serve as the company’s primary owner for quality compliance strategy, internal governance, and audit programs—responsible for ensuring processes, facilities, systems, and documentation are compliant, current, and inspection‑ready at all times.
The Director of Quality and Compliance is responsible for quality functions including disposition of enzymes, deviation resolution, CAPAs, change control, documentation supporting the suitability of the batches, completion of customer questionnaires, development/creation of quality systems and internal audits. This role will be based in Redwood City, CA.
If any of the below describes you, we would love to meet you!
Attention to detail with accuracy and thoroughness in all aspects.
Adaptable, highly accountable and able to prioritize effectively.
Excellent communication (verbal and e‑mail), interpersonal and organizational skills.
Ability to manage QA staff and projects (direct and indirect) and variable workloads to timelines.
In this role you will be responsible for: Quality Systems Ownership
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
Compliance & Inspection Readiness
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
Governance & Quality Oversight
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
Training & Documentation
Ensure training programs meet compliance requirements and role‑based proficiency expectations
Oversee document lifecycle management, ensuring documentation accuracy, traceability, and version control.
Quality Risk Management
Lead QRM programs using ICH Q9 principles.
Ensure processes are risk‑based, controlled, and continually improved.
Supplier & CMO/CTO Compliance
Oversee supplier qualification, ongoing monitoring, and quality technical agreements.
Ensure CMOs meet required GMP, compliance, and documentation standards.
Change Management
Drive structured, risk‑based change control ensuring sustained compliance with manufacturing and facility changes, tech transfers, and process modifications.
Data Integrity
Ensure ALCOA+ principles are embedded in operations.
Partner with IT/Automation to maintain validated systems where required.
The essential requirements of the job include:
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.
Additional experience that would be valuable for this role includes:
Technical experience or understanding in fermentation/DSP and quality control. CODEXIS PAY TRANSPARENCY CODEXIS PAY TRANSPARENCY: The anticipated salary range for candidates who will work in Redwood City is $225,000 to $250,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the role, type and length of experience in the industry, education, etc. Codexis is a multi‑state employer, and this salary range may not reflect positions that work in other states.
What can Codexis offer you?
Medical, Dental and Vision Insurance
Basic Life, AD&D, Short‑and‑Long‑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!
#J-18808-Ljbffr
57 - Quality Assurance
Employment Type:
Full Time
Location:
Redwood City, CA
Compensation:
$225,000 - $250,000 / year
Description Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a
Director of Quality and Compliance.
Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins. Codexis enzymes solve real-world challenges associated with small molecule pharmaceuticals manufacturing and nucleic acid synthesis. The Company is currently developing its proprietary ECO Synthesis™ platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route. Codexis enzymes can drive improvements, such as higher yields, reduced energy usage and waste generation, improve efficiency in manufacturing and greater sensitivity in genomic and diagnostic applications.
To meet the goals we’ve set for ourselves, we look for individuals who are driven, eager to grow and ready to embrace meaningful challenges. We empower employees to be authentic, ambitious, and agile and have the courage to act where they can make a positive impact.
Come join us on this journey to transform the enzyme engineering landscape for the betterment of human health.
About the Opportunity The Director of Quality and Compliance will provide leadership, strategy, and oversight for the company’s Quality Management System (QMS) to ensure alignment with regulatory expectations (FDA, EMA, ICH, ISO 9001, 21 CFR 210/211).
This role builds and maintains compliant quality systems, drives inspection readiness, ensures continuous improvement, and partners cross‑functionally to embed a culture of quality throughout asset development and manufacturing operations.
The Director will serve as the company’s primary owner for quality compliance strategy, internal governance, and audit programs—responsible for ensuring processes, facilities, systems, and documentation are compliant, current, and inspection‑ready at all times.
The Director of Quality and Compliance is responsible for quality functions including disposition of enzymes, deviation resolution, CAPAs, change control, documentation supporting the suitability of the batches, completion of customer questionnaires, development/creation of quality systems and internal audits. This role will be based in Redwood City, CA.
If any of the below describes you, we would love to meet you!
Attention to detail with accuracy and thoroughness in all aspects.
Adaptable, highly accountable and able to prioritize effectively.
Excellent communication (verbal and e‑mail), interpersonal and organizational skills.
Ability to manage QA staff and projects (direct and indirect) and variable workloads to timelines.
In this role you will be responsible for: Quality Systems Ownership
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
Compliance & Inspection Readiness
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
Governance & Quality Oversight
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
Training & Documentation
Ensure training programs meet compliance requirements and role‑based proficiency expectations
Oversee document lifecycle management, ensuring documentation accuracy, traceability, and version control.
Quality Risk Management
Lead QRM programs using ICH Q9 principles.
Ensure processes are risk‑based, controlled, and continually improved.
Supplier & CMO/CTO Compliance
Oversee supplier qualification, ongoing monitoring, and quality technical agreements.
Ensure CMOs meet required GMP, compliance, and documentation standards.
Change Management
Drive structured, risk‑based change control ensuring sustained compliance with manufacturing and facility changes, tech transfers, and process modifications.
Data Integrity
Ensure ALCOA+ principles are embedded in operations.
Partner with IT/Automation to maintain validated systems where required.
The essential requirements of the job include:
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.
Additional experience that would be valuable for this role includes:
Technical experience or understanding in fermentation/DSP and quality control. CODEXIS PAY TRANSPARENCY CODEXIS PAY TRANSPARENCY: The anticipated salary range for candidates who will work in Redwood City is $225,000 to $250,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the role, type and length of experience in the industry, education, etc. Codexis is a multi‑state employer, and this salary range may not reflect positions that work in other states.
What can Codexis offer you?
Medical, Dental and Vision Insurance
Basic Life, AD&D, Short‑and‑Long‑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!
#J-18808-Ljbffr