Quality Engineer - II

DI Program Specialist

We are seeking a highly motivated individual to join as a DI Program Specialist. You will work with the Quality Engineering team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the QE Sr Manager – DI Program Lead.

Job Responsibilities:

• Assist DI Lead in the implementation of the Global Data Integrity Program
• Collaborate in the review and creation of DI Standards and procedures as required.
• Prepare documents for internal and external information/audits
• Collaborate, perform or review data integrity assessments and mitigation work
• Supports project deadlines and ensures performance standards are met
• Ensures compliance with all Kite Pharma Data Integrity policies and procedures.
• Provides DI support during compliance inspections conducted by external sources
• Suggests resolution of DI compliance concerns to Program Lead
• Collaborate in the maintenance of the Data Integrity Program Charter updates and provide frequent status reports
• Participates in meetings, conference calls, and other interactions with stakeholders.
• Prepare and coordinate data/reports for the Integrity Management Program Team
• Conduct or assist in DI live or web-based training courses as required – virtually and on-site
• Assist with the development of training aids, including training handbooks, multimedia visual aids, computer tutorials, and other reference materials as needed
• Collaboration with stakeholders, business process owners, and system owners, in getting to understand their data needs and requirements
• Provide customer guidance, recommendations, and solutions throughout the entire DI implementation process.
• Share industry knowledge, proven process flows, and best practices to assist them in meeting their DI needs.
• Keep current on industry trends in the Data Integrity guidelines

Experience Requirements:

• 6+ years of relevant experience in a GMP environment-related field and a bachelor’s degree.
• Prior experience in the pharmaceutical industry is beneficial.
• Prior experience, quality, and/or mfg experience in the regulated industry for medicinal products.
• 6+ years’ experience in an FDA-regulated environment with a strong understanding of cGxP standards and Risk-based validation.
• Knowledge of Data Integrity guidances and industry standards (i.e., FDA, MHRA, PICs).
• Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biotechnology, pharmaceuticals, and medical devices.
• Experience in developing or reviewing Validation Plans, Requirements, Design Specifications, Test Protocols, Deviation management, Traceability matrices, and Validation Summary Reports.
• Cell culture experience is a plus.
• Knowledge of pharmaceutical manufacturing of biotechnology products, cell therapy products, and process development is a plus.
• Must be able to function and contribute as part of a team, have excellent communication skills, and contribute to team-based decisions.
• Ability to think critically and utilize troubleshooting and problem-solving skills.
• Ability to function efficiently and independently in a fast-paced, changing environment.
• Self-motivated and willing to accept temporary responsibilities outside of the initial job description.
• Well-developed computer skills and fluent with Client office applications.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
• Strong verbal and written communication skills.