Manager, Quality Assurance Operations
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, and with a subsidiary in Israel, developing novel cell therapies for treating cancer. The company’s next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT-Bio is seeking a Manager, Quality Assurance Operations to join our team at our GMP cell therapy production facility located in West Hills, CA.
This position may require working occasionally during weekends.
- Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area
- Provide Quality Assurance support involving manufacturing production issues
- Ensure that ImmPACT-Bio products are manufactured in compliance with site, regulatory and GMP guidelines
- Elevate issues affecting lot production or release to Management in a timely manner
- Ensure approval and timely delivery of Final Product Review and approve executed Manufacturing Production Records for Regulatory and ImmPACT-Bio compliance
- Compile and verify all batch related documents into a Final Product lot disposition package
- Perform quality investigations of manufacturing deviations, GMP and Quality System issues, non-conforming materials, and CAPA, as needed
- Gather metric information for use in continuous improvement of areas of responsibility, as needed
- Perform other duties as required to fulfill department and business needs
- Master's Degree or a Bachelor's Degree and 2+ years' experience in Quality Assurance
- Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility or an AA Degree and 4+ years' experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility or,
- High School Degree and 5+ years' experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
- Working knowledge of GMP, quality systems and regulatory requirements (21 CRF Part 11/210/211/600/610), practices/principles
- Knowledge of relevant ICH and FDA guidance documents
- Experience in identifying deviations and CAPA
- General knowledge of aseptic manufacturing processes
- Proficient in MS Word, Excel, Power Point and other applications
- Strong written and verbal communication skills
- Ability to communicate and work independently with scientific/technical personnel
- Experience with cell therapy manufacturing
- Experience with information electronics systems (LIMS, MES, Oracle EBS)
- Experience with internal audit
- Experience with Validation practices/principles + Knowledge of IQ/OQ/PQ
Compensation for the role will depend on several factors, including a candidate’s qualifications, skills, competencies, and experience.
ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.
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