Director of Quality and Compliance

Director of Quality and Compliance

Department: 57 - Quality Assurance

Employment Type: Full Time

Location: Redwood City, CA

Compensation: $225,000 - $250,000 / year

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 Code Evolver® 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.

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.

• 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…