Quality Assurance Manager

4 weeks ago

Irvine, California, United States CG ONCOLOGY INC Full time
Join Our Team at CG Oncology Inc.

We are seeking a highly skilled and experienced Quality Assurance Manager to join our team at CG Oncology Inc. As a key member of our commercial quality assurance team, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.

Key Responsibilities:
  • Develop and implement quality assurance programs, policies, and procedures to ensure compliance with cGMP regulations.
  • Manage vendor and partner relationships, ensuring that quality and compliance standards are met.
  • Perform document reviews and audits to ensure compliance with regulatory requirements.
  • Lead and manage cGMP auditing and inspection readiness programs.
  • Provide input on vendor quality system events, including change control, deviations, and CAPAs.
Requirements:
  • BS/BA in a relevant scientific discipline.
  • At least six (6) years of experience in quality systems and quality assurance processes, including development and documentation within the pharmaceutical/biotech industry.
  • A minimum of two (2) years of experience in managing QA projects, including directing and organizing personnel to complete critical timeline objectives.
  • Experience with commercial drug manufacturing and manufacturing process validation, familiarity with Federal laws and regulations affecting the pharmaceutical industry.
  • Comprehensive knowledge of GMP regulations, ICH, and FDA guidelines critical to product manufacture of a biologic and small molecule.
  • Ability to travel 25%.
What We Offer:
  • Competitive salary range: $140,000-$150,000.
  • Total Rewards package, including bonus and equity.
  • Well-Being Benefits, including fully remote work environment, rest and recharge benefits, holidays, retirement, health insurance, and more.

CG Oncology Inc. is an Equal Opportunity Employer. We are committed to building a diverse and inclusive team that shares our vision and values. If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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