Associate Director, Document Control Processes -Global Topic Owner

divh2Global Document Control Manager/h2pWere 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet./ppJoin Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next./ppWe 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./ppThe role is responsible for establishing, implementing, and overseeing the global document control program. This role ensures that all company documents are managed according to relevant regulations, standards, and internal policies. The role will lead the development and continuous improvement of document control processes, systems, and training to maintain document integrity, accuracy, and accessibility across the organization./ppResponsibilities:/ppProgram Development and Implementation:/pulliDevelop and implement the strategy for Document Control to drive sustained compliance of CGMP/GDP activities./liliDevelop and implement a comprehensive global document control program, including policies, procedures, and systems./liliOwn the technical content and sustainability of the Document Control topic, including the Policy, Standards, Standard Operating Procedures, and associated business enabling documents./liliEstablish and maintain a framework for document creation, review, approval, revision, storage, and obsolescence./liliEnsure the program aligns with relevant regulations (e.g., FDA, ISO), industry standards, and business needs./liliLead continuous improvement efforts and remaining current with regulatory changes and industry best practices./li/ulpGovernance and Strategic Direction:/pulliProvide strategic direction and oversight for the Global Document Control program./liliEstablish and monitor key performance indicators (KPIs) to assess program effectiveness./liliConduct regular audits and assessments to ensure compliance with document control requirements./liliIdentify and mitigate risks associated with document management./liliEnsure alignment with applicable regulations (e.g., FDA, ISO), internal policies, and business needs./liliManage interdependencies within and across QMS Topics./liliProvide leadership and technical direction for their Topic and associated support systems across a Global network./li/ulpSystem Management:/pulliOversee the selection, implementation, and maintenance of electronic document management systems (Veeva)./liliEnsure system meets the needs of the organization and supports efficient document workflows./liliManage system access, security, and data integrity./li/ulpTraining and Communication:/pulliDevelop and deliver training programs on document control policies and procedures./liliPromote a culture of document quality and compliance across the organization./liliCommunicate document control program updates and changes to stakeholders./li/ulpCollaboration and Stakeholder Management:/pulliPromote a Culture of Quality and Compliance across the network./liliCommunicate and collaborate with stakeholders on Topic updates and changes./liliCollaborate with cross-functional teams (e.g., Quality, Regulatory, Operations, RD) across a global network, to ensure document control needs are met./liliPartner with senior management to align the document control program with business objectives./liliManage relationships with external vendors and service providers./li/ulpContinuous Improvement:/pulliMonitor industry trends and best practices in document control./liliIdentify opportunities for process improvement and innovation./liliImplement changes to enhance the efficiency and effectiveness of the document control program./li/ulpBasic Qualifications:/pulliPhD with 2+ years of related experience in a biologics or pharma organization OR/liliMS/MA with 8+ years of related experience in a biologics or pharma organization OR/liliBS/BA with 10+ years of related experience in a biologics or pharma organization/liliHigh School diploma with 14+ years of related experience in a biologics or pharma organization/li/ulpPreferred Qualifications:/pulli10+ years of experience in the pharmaceutical and/or biotechnology industry operating within, or managing, a global document control network./liliExperience with Veeva eDMS is preferred/liliExcellent communication and influencing skills/liliProven ability to work and influence across a global network/liliAbility to collaborate and work cross-functionally/liliCreative problem solving approach and solutions based mindset/liliAbility to provide cross-functional leadership/li/ul/div