Job
Description
As a part of Bristol Myers Squibb, you will be taking on a challenging and meaningful role that can transform lives and careers. Here, you will have the opportunity to work on uniquely interesting projects every day, contributing to the latest breakthroughs in cell therapy and optimizing production processes. You will be part of high-achieving teams that offer uncommon opportunities for growth and development. **Key Responsibilities:** - 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 to ensure effective end-to-end process delivery. - Define TMF migration strategies in collaboration with business stakeholders for CROs, third parties, and newly acquired companies. - Work closely with eTMF Operations Lead and IT Business Partners to maintain high-quality document management and archival processes. - Lead global projects for optimizing the Quality Management System (QMS) and the end-to-end TMF process, ensuring compliance with industry standards. - Maintain global processes, procedures, and training materials for inspection readiness, in compliance with relevant requirements. - Drive and support audit/inspection readiness activities in collaboration with relevant functions within and outside Global Development Operations (GDO). - Define a control framework for in-house and outsourced studies, monitoring methods, metrics, and reporting mechanisms to ensure process quality and compliance. - Utilize metrics and trend analyses to identify and prioritize process improvements. - Maintain industry intelligence through training and participation in conferences to ensure a compliant TMF process. - Participate in benchmarking initiatives with peers externally to stay informed about evolving technologies and regulations. **Qualifications Required:** - Bachelor's Degree in a life science, natural science, or business. - Minimum of 10 years of clinical operations or relevant biopharmaceutical industry experience, with at least 5 years in TMF management and inspection readiness. - Strong knowledge of quality compliance processes, GCP, and global record retention requirements. - Experience with GCP related audits/inspections and project management skills. - Demonstrated leadership, communication, teamwork, and strategic thinking capabilities. - Ability to work in a matrixed organization and influence stakeholders across functions and divisions. If this role intrigues you, regardless of a perfect match with your resume, we encourage you to apply. Bristol Myers Squibb offers a supportive culture where individual talents are valued, and shared values drive the highest potential of each colleague. Your work here can be life-changing, contributing to the vision of transforming patients' lives through science. Apply now and be a part of something extraordinary. Please note that Bristol Myers Squibb is dedicated to providing workplace accommodations and support for individuals with disabilities. For any inquiries regarding accommodations or adjustments during the recruitment process, please contact adastaffingsupport@bms.com. As a part of Bristol Myers Squibb, you will be taking on a challenging and meaningful role that can transform lives and careers. Here, you will have the opportunity to work on uniquely interesting projects every day, contributing to the latest breakthroughs in cell therapy and optimizing production processes. You will be part of high-achieving teams that offer uncommon opportunities for growth and development. **Key Responsibilities:** - 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 to ensure effective end-to-end process delivery. - Define TMF migration strategies in collaboration with business stakeholders for CROs, third parties, and newly acquired companies. - Work closely with eTMF Operations Lead and IT Business Partners to maintain high-quality document management and archival processes. - Lead global projects for optimizing the Quality Management System (QMS) and the end-to-end TMF process, ensuring compliance with industry standards. - Maintain global processes, procedures, and training materials for inspection readiness, in compliance with relevant requirements. - Drive and support audit/inspection readiness activities in collaboration with relevant functions within and outside Global Development Operations (GDO). - Define a control framework for in-house and outsourced studies, monitoring methods, metrics, and reporting mechanisms to ensure process quality and compliance. - Utilize metrics and trend analyses to identify and prioritize process improvements. - Maintain industry intelligence through training and participation in conferences to ensure a compliant TM
