Codexis

Associate Director, Quality Assurance

64 - QC & Analytical Development - Redwood City, CA - Full Time

Associate Director or Senior Manager, Quality Assurance

At Codexis, we are creating sustainable chemicals, renewable ingredients that make industry more efficient, productive and profitable.  Industrial biotechnology from Codexis reengineers enzymes – nature’s catalysts – and puts them to work to solve real global challenges for the world’s largest companies.  We provide our customers with optimized, faster, flexible, cost-advantaged biosolutions and products tailored for their needs.

 

Codexis seeks a highly motivated Associate Director, Quality Assurance reporting to the AVP, Analytical Development, Quality & Regulatory.

 

The Senior Manager or Associate Director, Quality Assurance, is responsible for providing leadership and direction for all internal quality operations. This requires technical understanding of enzyme production (fermentation and DSP) and QC, with attention to detail for assessment and approval of quality activities such as 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.

 

Responsibilities:

  • 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.
  • Development, establishment and maintenance of internal quality systems and processes such as deviations, investigations, change control, CAPAs, training, internal auditing, document review/editing 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.
     

Requirements:

  • BA or BS degree in a scientific discipline; advanced degree in sciences preferred.
  • Technical experience in fermentation and/or quality control.
  • At least 10 years of experience in Quality Assurance at an operational level supporting manufacturing and quality control in a pharmaceutical or biotech environment.
  • Previous responsibility for assessing whether products meet specifications, required quality standards and determining disposition of products.
  • Experience in the development, establishment and maintenance of internal quality systems and processes such as deviations, investigations, change control, CAPAs, internal audits and training.
  • Ability to technically assess deviations, investigations, change control, CAPAs, etc. for compliance with quality standards.
  • Ability to lead and influence other departments to maintain compliance with Codexis quality standards.
  • Attention to detail with accuracy and thoroughness in all aspects of this role.
  • 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.
  • In-depth knowledge and application of ICH Guidelines and quality fundamentals (deviations, change control, root cause analysis, etc.) to daily work product.

 

The position comes with a competitive compensation and benefits package.  For more information about our plans for the future, and to be considered for this career opportunity, please visit www.codexis.com.

 

EOE

PRINCIPALS ONLY 

NO AGENCIES OR THIRD PARTIES

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