The Sr. Manager/Associate Director - Computer System Validation is an individual contributor, responsible for strategically managing the ImmunityBio computer system validation and data integrity programs. This position will also provide quality oversight for the NantOmics in-vitro diagnostic test.
This position interacts cross-functionally with Computerized System Owners, Business Process Owners, and Information Technology to manage the computerized systems lifecycle and implement integrated computer systems that improve the effectiveness, efficiency, and compliance 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 biopharmaceutical company that is transitioning to the commercial phase.
DUTIES AND RESPONSIBILITIES
Develop, implement and maintain a risk-based computer system validation program for lifecycle management of GxP computerized systems in compliance with current regulatory requirements and standards.Develop, implement and maintain the data integrity program in compliance with current regulatory requirements and standards.Provide management and strategic leadership to drive consistent approaches to computer system validation across the entire ImmunityBio organization.Author, review and/or approve computer system validation documentation (Validation Plans, Risk Assessments, Specifications, Protocols and Reports, Trace Matrices, etc.) and change controls for compliance with applicable business and regulatory requirements.Identify and provide leadership for continuous improvement initiatives for ImmunityBio related to computer systems validation and data integrity.Ensure risk assessment, validation, implementation, change management, and periodic review of electronic systems used across GxP operations are conducted and all associated documentation is completed in compliance with applicable business and regulatory requirements to ensure computer systems are maintained in a controlled and validated state. Participate as the computer system validation and data integrity Subject Matter Expert during internal and external audits/inspections.Support the supplier quality program by evaluating and/or auditing computer system-related service providers. Evaluate vendor software development lifecycle practices and methodology to confirm compliance with good engineering practices and applicable regulatory requirements and standards.Responsible for all software quality assurance activities for the NantOmics in-vitro diagnostic (IVD) test such as evaluation of software lifecycle (SLC) deliverables for compliance with Standard Operating Procedures, and applicable FDA Guidelines including but not limited to 21 CFR 211 and 21 CFR 820. Lead or participate in document reviews, assessments, risk analyses, and other software quality assurance activities.May conduct other Quality related duties, as assigned.
REQUIRED COMPETENCIES (KNOWLEDGE, SKILLS, AND EXPERIENCE)
Bachelor's Degree in a life science or engineering discipline with a minimum of 8-10 years of quality experience in a GMP-regulated Biologics, Medical Device or Pharmaceutical environment.Extensive knowledge and experience in 21 CFR 210/211, 21 CFR 1271, 21 CFR 820, 21 CFR Part 11 and strong knowledge of GAMP 5 principles.Experience supporting computer systems validation, including MES, LIMS, ERP, quality/regulatory applications and/or lab systems.Strong technical understanding of computer system design, architecture, implementation, integration, and IT infrastructure.Experience in requirements gathering, analysis technologies, software verification/validation, configuration management techniques, and documentation standards.Able to prepare written communications with clarity and accuracy. Must have strong authorship and be able to critically review reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.Able to communicate complex topics in simple terms to any audience.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 deadlinesStrong problem-solving and analytical skills with demonstrated ability to be detail-oriented while managing multiple projects simultaneously.Must be proficient in Microsoft Office (Excel, Word, Access, PowerPoint, Visio) and Adobe Professional software.