MANAGER, QUALITY ASSURANCE

Manager, Quality Assurance

Department : 64 - QC & Analytical Development

Employment Type : Full Time

Location : Redwood City, CA

Description

Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a Manager, Quality Assurance.

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 for 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, agile and have the courage to take action 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 Manager, Quality Assurance is responsible for managing various aspect of Quality Operations to ensure compliance with the company's procedures, policies, quality oversight of external manufacturing, internal manufacturing, QC and product release.

This role will be based in Redwood City, CA.

If any of the below describes you, we would love to meet you!

• Ability to manage projects (direct and indirect) and variable workloads to timelines.
• Attention to detail with accuracy and thoroughness in all aspects, including organizational skills.
• Previous experience in oversight and approval of quality systems documentation.

In this role you will be responsible for :

• Quality oversight of the ECO Synthesis program and Pharma Manufacturing business including review of CMO deviations, change controls and disposition documentation supporting batch release.
• Collaborates with cross functional departments to achieve the objectives of the company. Work directly with internal and external operational groups to ensure that products meet quality standards, specifications, and requirements.
• Manage and maintain internal quality systems and processes.
• Provides direction and decision making for Quality systems records and reports such as deviations, lab investigations, change control, CAPAs, product complaints, SOPs, and validation protocols / reports.
• Develop and execute continuous improvement initiatives of QA processes and SOPs.
• Manage and support internal, external, and customer quality audits.
• Manage Codexis Quality System Metrics and reporting.

The essential requirements of the job include :

• Bachelor's degree or equivalent in Life Science or related discipline. Advanced degree preferred.
• 8 or more years of experience in Quality Assurance supporting manufacturing and quality control in a pharmaceutical or biotech environment or similar.
• Experienced leveraging vendor Quality Management Systems to assure phase appropriate quality compliance.
• Previous experience in oversight and approval of quality systems documentation.
• Understands how to apply ICH Guidelines, ISO9001, and / or ISO13485 and phase appropriate GMP regulations.

Additional experience that would be valuable for this role includes :

• Good knowledge base and direct experience in fermentation / Down Stream Process (DSP) and Quality Control.
• Experience in providing QA guidance for computerized system implementation and validation.
• Experience in providing quality guidance to internal functional teams.

CODEXIS PAY TRANSPARENCY : The anticipated salary range for candidates who will work in Redwood City is $138,500 to $162,000.

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 job, type and length of experience within 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-Term 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!
9 hours ago