Job Description

QA Documentation Lead

Kite, a Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

Your responsibilities

• Supervising QA Documentation personnel including organizing and prioritizing workflow and daily tasks
• Ensuring timely distribution of controlled issued documentation to operational departments.
• Writing and revising standard operating procedures (SOPs) and work instructions for continuous improvement of systems.
• Ensuring quality of on-the-job trainings and provides hands-on day-to-day guidance to the personnel
• Ensuring inventory of operational materials are maintained
• Maintaining/presenting monthly document control metrics.
• Identifying areas for improvements and working on implementation after alignment.
• Providing additional support and assistance on tasks and projects with minimal direction from management.
• Providing oversight of staff performing activities in support of document control.
• Providing input for performance evaluations.
• Providing support to internal and regulatory audits/inspections as required.
• Creating, maintaining, and contributing to continuous improvement of document issuance operation.
• Ensuring deviation investigations are completed timely and right corrective actions are defined and implemented.
• Additional duties as assigned.

Skill requirements

• Demonstrating advanced technical knowledge in industry practices.
• Demonstrating advanced knowledge of computer systems which support document control processes.
• Demonstrating the ability to clearly and concisely present/ explain documentation requirements and deviations to multiple internal audiences.
• Demonstrating an ability and desiring to supervise and support staff.
• Demonstrating good coping skills and analytical problem-solving skills.

• 5+ years in GMP as QA
• 2+ years team management experience