Associate Director, TMF Compliance Lead

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:

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, 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.

Education/Degree(s):

• A minimum of a Bachelor's Degree (or equivalent degree) is required. Degree in a life science, natural science or business is preferred. 

Experience:

• 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.

Skills/Abilities:

• 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

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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