Quality Assurance Manager
4 days ago
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.
- 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%.
- 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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