Associate Director, Quality Assurance
Codexis, Inc. (Nasdaq: CDXS) is a protein engineering industry leader with successful track record of developing novel enzymes used as biocatalysts for the commercial production of small molecule pharmaceuticals, diagnostic tools, chemicals used in the food industry, as well as multiple other applications. Codexis has also applied its CodeEvolver technology platform to discover and develop novel biotherapeutics for the treatment of rare genetic disorders, among other indications with significant unmet medical need.
Codexis seeks a highly motivated Associate Director, Quality Assurance reporting to the VP, Analytical Development, Quality & Regulatory to manage internal Quality operations.
Associate Director, Quality Assurance, is responsible for providing leadership and direction for all internal quality operations. This consists of maintaining high levels of quality for the manufacturing and quality control of Codexis products. A technical understanding of enzyme production (fermentation and DSP) and QC is required. Responsibilities include disposition of enzyme, deviation resolution, CAPAs, change control, lab investigations, documentation supporting the suitability of the batches, completion of customer questionnaires, development/creation of quality systems and internal audits. Requisites for this position are attention to detail for assessment and a fundamental knowledge of quality systems to reason through routine, and particularly non-routine, quality situations.
- Product disposition and QA support for the manufacture and testing of Codexis products. Work directly with internal operational groups to ensure that products meet all required quality standards, specifications and requirements.
- Provide QA leadership and influence other departments to ensure that internal operations achieve and maintain compliance with Codexis quality standards.
- Develop, establish and maintain internal quality systems and processes.
- Technical review of deviations, investigations, change control, CAPAs and reports/memos.
- Provide QA guidance and support for raw material and contract lab qualification.
- Write and review documents for consistency with quality principles and existing quality systems.
- Coordinate and facilitate with CMOs to achieve quality objectives and resolution of quality issues.
- Lead internal audit program and prepare for and host customer quality audits.
- Completion of customer quality questionnaires and creation of certificates for various assurances.
- BA or BS degree in a scientific discipline; advanced degree in sciences preferred.
- A minimum of 15 years of experience in Quality Assurance supporting manufacturing and quality control in a pharmaceutical or biotech environment.
- Technical experience in fermentation/DSP and quality control.
- Attention to detail with accuracy and thoroughness in all aspects of this role.
- A fundamental understanding of quality systems and the ability to extrapolate this knowledge to develop solutions to quality situations.
- In-depth knowledge and application of ICH Guidelines.
- Previous responsibility for assessing whether products meet specifications, required quality standards and determining disposition of products.
- Exceptional writing skills for document, memo and report writing and review.
- Excellent communication (verbal and e-mail), interpersonal and organizational skills.
- Ability to manage staff and projects (direct and indirect) and variable workloads to timelines.