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.



  • 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.


  • 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





Apply: Associate Director, Quality Assurance
* Required fields
First name*
Last name*
Email address*
Phone number*

Attach resume as .pdf, .doc, .docx, .odt, or .rtf (limit 5MB) or paste resume

Paste your resume here or attach resume file

Cover Letter*
In 150 characters or fewer, tell us what makes you unique. Try to be creative and say something that will catch our eye!*
What is the highest college degree you have earned?*
Do you currently reside within commuting distance of Redwood City, California?*
Are you authorized to work lawfully in the United States for any employer?*
How many years experience do you have in Quality Assurance at an operational level supporting manufacturing and quality control in a pharmaceutical or biotech environment?*
If you were referred to this position by a Codexis employee, please write the name of the person referring you. If you were not referred to this position, please type NA.*
The following questions are entirely optional.
To comply with government Equal Employment Opportunity / Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.

Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status

Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 1/31/2020
Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities.i To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Please check one of the boxes below:

YES, I HAVE A DISABILITY (or previously had a disability)

Your Name Today's Date
Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

iSection 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.