Lead and provide strategic direction across R&D functions to ensure high-quality TMF end to end processes for in-house and outsourced studies. Direct management of TMF Process Leads and TMF System and Business Lead, with matrix support to other members of the department including TMF Study Leads and Archival Leads, eTMF Operations Analysts, and the Central Upload and QR team, to ensure effective end-to-end process delivery. In collaboration with business stakeholders, including IT Business Partners, define TMF migration strategies from CROs, third parties and newly acquired companies. Work closely with the eTMF Operations Lead, the eTMF System Business Owner and IT Business Partners to ensure the end-to-end document management and archival process is of high quality and in line with industry standards. Lead global, cross functional projects for the optimization of the Quality Management System (QMS) and the end-to-end TMF process (including archival and retrieval of study documentation in the TMF), including partnering with internal business stakeholders IT, third party vendors, external consultants, etc Maintain global processes, procedures, and training materials to ensure inspection readiness for completed studies, in compliance with ICH E6 requirements, BMS Global Quality Standards, BMS Quality Management System and ALCOA-CCEA principles. Support the development and governance of global processes for TMF by close cooperation with relevant functions and participation of TMF Process Leads. Identify the named archivist(s) for paper and electronic records, as required by regulations, and ensure training, support, and coaching is provided, as required. Drive and support BMS audit/inspection readiness activities in collaboration and consultation with the Global TMF Process Owner and all relevant functions within and outside Global Development Operations (GDO). Liaise with Global Quality, Business Risk Management and Compliance, and other in-scope functional leadership to ensure the TMF team is empowered and supported to implement mitigations and improvements as required. Set the strategic vision for, and advise study teams on, TMF inspection readiness activities. Define a control framework for in-house and outsourced studies and related monitoring methods, including data collection and analyses, metrics and associated targets, and reporting mechanisms to ensure upstream and downstream flow of information, process quality, compliance and effectiveness. Utilize metrics and trend analyses to identify and prioritize process improvements. Provide data and input to drive continuous improvement efforts across the enterprise as applicable. Build and maintain industry intelligence and process expertise through training and participation at conferences and in industry forums. Maintain awareness of evolving regulations, standards, technology, and best practices and channel appropriate intelligence into the BMS business model to ensure a compliant TMF process delivered to a high standard. Participate/lead benchmarking initiatives with peers externally to stay abreast of new ways of working and evolving technologies. Bring ideas and external Regulatory intelligence to internal stakeholders for assessing impact on TMF processes. Maintain high level knowledge of global record retention requirements as well as changes at local level. A minimum of a Bachelor's Degree (or equivalent degree) is required. Degree in a life science, natural science or business is preferred. A minimum of 10 years of clinical operations, regulatory, pharmacovigilance, or other relevant biopharmaceutical industry experience, including at least 5 years in TMF management and inspection readiness or related position. Quality compliance processes and regulations, e.g., Good Clinical Practices (GCP) and Good Documentation practices. Processes related to the maintenance of an inspection ready TMF. Thorough knowledge of the main platforms used across the industry to maintain an electronic TMF (eTMF) and related processes. Strong knowledge of global record retention requirements as well as changes at local level. Experience with GCP related audits/inspections is required. Strong program and project management experience with proven track-record of several years managing cross-functional programs and ability to manage multiple, simultaneous projects. Demonstrated influential leadership, expertise and experience with senior level interactions and influence across internal and external stakeholders Demonstrated Enterprise mindset to be able to think and act across functions and divisions. Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives. Demonstrated people management experience. Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats. Strong and demonstrated strategic thinking capability with strong project management focus and ability to focus on execution of strategic decisions while balance conflicting priorities. Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. Demonstrated change agility in anticipating and leading others through change and ambiguity. Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising compliance. Occasional