ImmPACT Bio is looking for an exceptional individual to join our growing team as Senior Director, Head of Quality. This position will report directly to the Chief Technical Officer and be responsible for the overall leadership of the Quality function at ImmPACT Bio. Direct organizational responsibilities will include Quality Assurance, Quality Control, and Validation/Quality Engineering, and will include responsibility for regulatory compliance oversight of internal and external manufacturing operations. The successful candidate will work cross-functionally, in a highly collaborative environment, to design and scale quality processes, and support manufacturing, as well as draft documentation for regulatory filings to advance the Company’s product portfolio.
Responsibilities include, but are not limited to:
- Hire and lead a team of quality professionals capable of overseeing a rapidly growing organization while establishing and maintaining high performance standards
- Establish department vision, strategy, annual objectives, and budget aligned with company and the technical operations objectives
- Provide company-wide leadership to realize a culture of quality across all operations, promoting the escalation of quality issues for appropriate corrective action
- Develop and implement a GxP Quality Management System fit for purpose and consistent with current regulatory and industry standards
- Ultimate company decision maker regarding product and material disposition, quality objectives, and overall company GxP regulatory compliance
- Role model company values both internally with staff and externally with key business stakeholders and partners
Experience and Qualification Requirements:
- Bachelor’s degree in Science or Engineering, with advanced degree strongly preferred
- Minimum of 10 years in Quality/Technical Operation roles with cross functional experience preferred
- 5 -10 years of management and leadership responsibility with preference for demonstrate experience of recruiting and developing a high performing team
- 3+ years’ experience with cell and gene therapy products, manufacturing, and testing
- Excellent analytical problem-solving skills including a pragmatic decision-making approach balancing development phase and regulatory expectations while prioritizing patient safety
- Experience with the design, development and management of GxP Quality Management Systems with an understanding of how to mature the system to support product development objectives
- Experience with the application of risk management tools across process development, manufacturing, and quality
- Experience with CMC regulatory submission content development for IND and BLA stages of development
- Experience with successfully managing regulatory inspections of GMP manufacturing and testing facilities
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’s lead program, a bispecific “OR-gate” CAR, with an excellent tolerability profile, has demonstrated durable complete remission (CR) in 88% of patients treated so far.
ImmPACT Bio provides a generous rewards package, with competitive compensation and health benefits, with career progression benefits as part of a rapidly growing multi-platform company.