Associate Director, TMF Compliance Lead

As a Senior Manager, Trial Master File (TMF) Operations at Bristol Myers Squibb, you will play a crucial role in leading and providing strategic direction across R&D functions to ensure high-quality TMF end-to-end processes for in-house and outsourced studies. Your responsibilities will include: - Leading and providing strategic direction across R&D functions for high-quality TMF end-to-end processes - Managing TMF Process Leads and TMF System and Business Lead - Defining TMF migration strategies in collaboration with business stakeholders - Ensuring document management and archival processes are of high quality and in line with industry standards - Leading global, cross-functional projects for the optimization of the Quality Management System and the end-to-end TMF process - Maintaining global processes, procedures, and training materials for inspection readiness - Supporting the development and governance of global processes for TMF - Driving and supporting BMS audit/inspection readiness activities - Defining a control framework for in-house and outsourced studies - Utilizing metrics and trend analyses to identify and prioritize process improvements - Building and maintaining industry intelligence and process expertise through training and participation at conferences - Participating in benchmarking initiatives with peers externally Qualifications required for this role include: Education/Degree(s): - A minimum of a Bachelor's Degree (or equivalent degree) is required, with a degree in a life science, natural science, or business preferred Experience: - Minimum of 10 years of clinical operations, regulatory, pharmacovigilance, or other relevant biopharmaceutical industry experience - At least 5 years in TMF management and inspection readiness or related position - Strong program and project management experience Skills/Abilities: - Demonstrated influential leadership and expertise with senior level interactions - Ability to work in a matrixed organization and influence areas not under direct control - Strong teamwork, interpersonal, and communication skills - Strategic thinking capability with a focus on execution of decisions - Change agility in leading others through change and ambiguity - Ability to provide innovative ideas that create value and seek new information without compromising compliance If you believe you possess the required qualifications and skills for this role, we encourage you to apply. Your work at Bristol Myers Squibb has the potential to transform patients" lives through science and offer you a fulfilling and challenging career opportunity.,