Senior Manager, Quality Information Systems

ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”

POSITION SUMMARY

The Senior Manager – Quality Information Systems is responsible for developing, implementing, maintaining and providing quality oversight of the following programs:

• Data Integrity
• Enterprise Computer Systems Validation (CSV)/Computer Software Assurance(CSA) Oversight

This position interacts cross-functionally across the ImmunityBio organization.

The successful candidate is proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline-focused and is flexible in their work scheduling to meet the demands of a multi-product clinical phase bio-pharmaceutical company that is transitioning to the commercial phase.

ESSENTIAL FUNCTIONS

• Develop, implement and maintain the Data Integrity (DI) program for compliance with current regulatory requirements and standards:

• Promote the understanding of, and ensuring compliance to, ALCOA+ principles and associated regulatory requirements and standards
• Responsible for overall performance of Data Integrity program in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with regulatory requirements and standards
• Drives prioritization of ImmunityBio GxP DI assessment and remediation in collaboration with Management and providing oversight to execution
• Leads Data Integrity related due diligence activities with CXOs
• Development and tracking of Data Integrity metrics
• Function as the primary Quality representative for CSV Information Technology enterprise programs to ensure compliance with current regulatory requirements and standards.
• Partner with IT on the development of risk-based CSV/CSA processes to support GXP enterprise systems.
• Quality oversight of the validation, implementation and change management of enterprise-wide computer systems.
• Effectively partner with IT, Validation and other key stakeholders to ensure compliant management of the enterprise systems and coordinated deployment of new processes, enhancements or system updates.
• Quality review & approval of IT deviations, change controls or other quality records

• Lead and/or support investigations related to data integrity and/or enterprise systems.
• Support audits of enterprise systems, data integrity, and suppliers providing those systems, software and other relevant services (as required).
• Participate as Data Integrity Subject Matter Expert and the CSV/CSA Quality representative for enterprise systems during internal and external audits/inspections.
• Identify and provide leadership for continuous improvement initiatives for ImmunityBio related to Data Integrity programs and Quality Information Systems.
• May conduct other Quality related duties, as assigned.

EDUCATION/EXPERIENCE REQUIREMENTS

• Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 10 years of experience in a GMP-regulated Biologics or Pharmaceutical environment.
• Experience in 21 CFR 210/211, 1271, 810 and 2001/83/EC, 2006/17/EC and 2006/86/EC.
• Expertise with 21 CFR Part 11, Annex 11 and GAMP 5 concepts and applications
• Experience in a clinical and/or commercial phase pharmaceutical environment.
• Experience with Contract Manufacturing Organizations (preferred)
• Experience in and /or knowledge of enterprise systems, computer system validation and Data Integrity
• Knowledge and experience in preparing and managing regulatory authority inspections, including direct interaction with inspectors.
• Experience hiring, training, and leading cross-functional teams.

REQUIRED COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES

• Strong verbal and written communication skills.
• Demonstrated ability to interface with senior leaders and cross-functional teams.
• Ability to work collaboratively with others from any functional area or background, to influence thinking, and gain acceptance.
• Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills with a strong sense of personal accountability for work tasks.
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
• Ability to gown and gain entry into manufacturing areas.
• Must be proficient in Microsoft Office (Excel, Word, Access, PowerPoint, Visio) and Adobe Professional software.

*All hires are subject to passage and completion of a background check.

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.