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Director, Commercial Quality Assurance
1 month ago
ImmunityBio, Inc. is seeking a highly skilled Director, Commercial Quality Assurance to join our team. As a key member of our commercial organization, you will be responsible for ensuring the quality and compliance of our commercial products.
Key Responsibilities:- Design, plan, implement, and operate quality control programs to ensure product reliability, quality, efficacy, and compliance with applicable regulations.
- Oversee laboratory testing, including in-house and outsourced testing, to ensure compliance with quality standards.
- Develop and implement methods to increase efficiencies and productivity, and to improve knowledge of product safety, purity, efficacy, potency, and stability.
- Ensure Quality Control decisions align with Quality System, GMP, and regulatory requirements.
- Provide budgets for current and future operations, including strategy and plans for laboratory relocations and new laboratory implementation.
- Develop and mentor the Analytical Quality Control staff to perform at a commercial level of compliance.
- Oversee the performance of designated staff, including interviewing, hiring, training, and performance management.
- Bachelor's degree in biology, chemistry, or other scientific related field with 15 years of related quality experience, or Master's degree with 10 years of experience, or Ph.D. with 8 years of experience.
- Extensive experience with assay qualification, validation, and transfer activities.
- Experience with a start-up pharmaceutical company preferred.
- Thorough understanding of biologics manufacturing processes, including cell culture, purification, and analytical characterization techniques.
- Proven track record of successfully leading QC teams, driving quality initiatives, and managing regulatory inspections.
- Competitive salary range: $178,000 - $215,000 annually.
- Discretionary bonus and equity award.
- Comprehensive benefits package, including medical, dental, and vision plans, health and financial wellness programs, and 401(k) retirement plan with company match.
- Opportunity to work with a collaborative team and contribute to the development of cutting-edge technology.
ImmunityBio is an equal opportunity employer dedicated to diversity in the workplace. We are committed to providing a safe and inclusive environment for all employees. If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.
