Quality Assurance Manager

6 days ago

Redwood City, California, United States BioSpace, Inc. Full time
Job Details

Department
64 - QC & Analytical Development

Employment Type
Full Time

Location
Redwood City, CA

Workplace type
Onsite

Description
Codexis, a biotechnology company based in Redwood City, CA, is seeking a Quality Assurance Manager to join its team. As a leading enzyme engineering company, Codexis leverages its proprietary CodeEvolver technology platform to discover, develop, and enhance novel, high-performance enzymes and other classes of proteins. The company's enzymes solve real-world challenges associated with small molecule pharmaceuticals manufacturing and nucleic acid synthesis. Codexis is currently developing its proprietary ECO SynthesisTM platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route. The company's 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 its goals, Codexis looks for individuals who are driven, eager to grow, and ready to embrace meaningful challenges. The company empowers employees to be authentic, ambitious, agile, and have the courage to take action where they can make a positive impact.

Codexis is committed to fostering a culture of innovation, collaboration, and continuous improvement. The company offers a competitive compensation package, including medical, dental, and vision insurance, basic life, AD&D, short- and long-term disability insurance, 401k with company match, company equity, and generous paid time off, including 18 company holidays, vacation, and wellness time. Additionally, Codexis offers an annual lifestyle account for reimbursement of fitness programs, equipment, and more, employee stock purchase program, flexible spending accounts, student debt program, mental health wellness program, subsidized onsite lunch program, onsite gym facilities, paid parental leave, and more.

The Quality Assurance Manager will be responsible for managing various aspects 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 you have the following skills and experience, 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.

Responsibilities
The Quality Assurance Manager will be responsible for:

  • Quality oversight of the ECO SynthesisTM 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.

Requirements
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.

Preferred Experience
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.

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, including but 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.

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