Associate Director, Global Quality Systems - Document Control and Training

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

The role is responsible for establishing, implementing, and overseeing Kite’s Global Document Control and Training Programs. This role ensures that all company documents are managed according to relevant regulations, standards, and internal policies, in addition to supporting the oversight and on-going development of Kite’s Training processes and systems.

This role will oversee the implementation of systems and procedures, and support development of the strategy, that ensure organizational documents are maintained with high levels of integrity, accuracy, and accessibility. The leader will also champion the advancement of training systems, working to refine and expand the training programs to address evolving business needs and industry standards.

• Develop and implement the strategy for Document Control and Training processes to drive sustained compliance of cGMP/GDP activities.
• Develop and implement comprehensive Global Document Control and Training processes, including policies, procedures, and systems.
• Own the technical content and sustainability of the Document Control and Training processes, including the Policy, Standards, Standard Operating Procedures, and associated business enabling documents.
• Establish and maintain a framework for document management and training delivery including creation, review, approval, revision, storage, and obsolescence.
• Ensure that the processes aligns with relevant regulations (e.g., FDA, ISO), industry standards, and business needs.
• Lead continuous improvement efforts and remain current with regulatory changes and industry best practices.

• Provide strategic direction and oversight for the Global Document Control and Training processes.
• Establish and monitor key performance indicators (KPIs) to assess process effectiveness.
• Conduct regular audits and assessments to ensure compliance with internal and external requirements.
• Identify and mitigate risks associated processes.
• Ensure alignment with applicable regulations (e.g., FDA, ISO), internal policies, and business needs.
• Manage interdependencies within and across QMS Topics.
• Provide leadership and technical direction for their Topic and associated support systems across a Global network.

• Oversee the selection, implementation, and maintenance of electronic document management (Veeva) and learning management systems.
• Ensure systems meet the needs of the organization and supports efficiency and agility.
• Manage system access, security, and data integrity.

• Develop and deliver training programs on process policies and procedures.
• Promote a culture of quality and compliance across the organization.
• Communicate program updates and changes to stakeholders.

• Promote a Culture of Quality and Compliance across the network.
• Communicate and collaborate with stakeholders on Topic updates and changes.
• Collaborate with cross-functional teams (e.g., Quality, Regulatory, Operations, R&D) across a global network, to ensure document control and training needs are met.
• Partner with senior management to align processes with business objectives.
• Manage relationships with external vendors and service providers.

• Monitor industry…