Quality Assurance Manager

4 weeks ago


Plano, Texas, United States Codexis Full time

About the Opportunity:

The Manager, Quality Assurance is 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 a dynamic environment where you will be working closely with cross-functional departments to achieve the objectives of the company.

Key Responsibilities:

  • 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.

Requirements:
  • 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.

What Codexis Offers:
  • 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


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