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Director, Commercial Quality Assurance

2 months ago

Culver City, California, United States ImmunityBio Full time
Job Summary

The Director, Commercial Quality Assurance will be responsible for leading the development and implementation of quality control programs to ensure product reliability, quality, efficacy, and compliance with regulatory requirements. This role will oversee laboratory testing, method development, and validation, as well as ensure alignment with Quality System, GMP, and regulatory requirements.

Key Responsibilities
  • Design, plan, and implement quality control programs to ensure product reliability, quality, efficacy, and compliance with regulatory requirements.
  • Oversee laboratory testing, method development, and validation to ensure accuracy and reliability.
  • Ensure alignment with Quality System, GMP, and regulatory requirements.
  • Develop and implement strategies to increase efficiencies and productivity, and to improve knowledge of product safety, purity, efficacy, potency, and stability.
  • 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, and training employees, planning, assigning, and directing work, appraising performance, rewarding and disciplining employees, addressing complaints, and resolving problems.
Requirements
  • Bachelor's degree in biology, chemistry, or other scientific related field with 15 years of related quality experience, or Master's degree in biology, chemistry, or other scientific related field with 10 years of related quality experience, or Ph.D. in biology, chemistry, or other scientific related field with 8 years of related quality experience.
  • Extensive experience with assay qualification, validation, and transfer activities.
  • Experience with a FDA PLI, Surveillance, or other inspection, with an acceptable outcome.
  • Experience with a start-up pharmaceutical company preferred.
What We Offer

ImmunityBio offers a competitive total rewards benefits package, including medical, dental, and vision plan options, health and financial wellness programs, employer assistance program, company-paid and voluntary life/AD&D, short-term and long-term disability, healthcare and dependent care flexible spending accounts, 401(k) retirement plan with company match, 529 education savings program, voluntary legal services, identity theft protection, pet insurance, and employee discounts, rewards, and perks. We also offer paid time off, including 11 holidays, exempt employees are eligible for unlimited PTO, non-exempt employees are eligible for 10 vacation days, 56 hours of health pay, 2 personal days, and 1 cultural day.

We are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity, and/or expression, or other status protected by law.

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation, we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.