Regional Clinical Operations Process Lead

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Key Responsibilities and Major Duties

Overall responsibilities

In close collaboration with the Global Process Owner, serve as the process lead for a QMS process ensuring it

remains in a state of control and is both effective and efficient

Supporting the process architecture of the integrated Quality Management System (QMS), lead a process workstream designed to monitor and improve said process(es) within the integrated GxP QMS framework

Work effectively across the matrix by engaging with the broader process owner network and local site or function process owners in designing and deploying QMS process improvements.

Identify and track progress against key project milestones partnering with applicable business, quality and other enabling functions and any external providers to ensure overall project success

Actively engage with leadership from business case development through program delivery, broker the delivery of critical programs within the portfolio, ensure organizational alignment on scope, schedule, quality, benefits and implement and monitor appropriate controls to proactively deal with barriers to completion

Navigate cross-functional team through ambiguity towards to a clear and actionable decision

Participate/lead regulatory surveillance and benchmarking initiatives with peers externally to stay abreast of changes in regulations that affect impacted processes and also to identify new ways of working and evolving technologies in this space

Define and lead the development of metrics through standard queries and reports with system functionality

Develop, Deploy, and Maintain Assigned Processes

Maintain global processes, procedures, and training materials in compliance with Global GxP requirements, BMS Global Quality Standards, and BMS' Quality Management System (QMS) principles of integrated, patient centric, and risk-based decision-making

Support deployment of global process by close cooperation with relevant functions and site/country leads

Provide training, support, and coaching as required

Define Community of Practice (COP), including roles, operating mechanisms, communication strategies, and levels of training and access

Liaise with Quality Leadership Team and other functional leaders to identify and empower COP members

Provide leadership, coaching, and training for COP including both the technical processes and the behaviors necessary to optimize process execution

Continuous Process Improvement

Utilize metrics and COP operating mechanisms to identify and prioritize process improvements

Provide data and input to drive other continuous improvement efforts across the enterprise as applicable, which may include priority and timing collaboration with other PL

Lead efforts to scope, plan, and implement process improvements including accountability for sustainable improvements, such as process, procedure, systems, and training material changes; and use of appropriate change management and communication principles

Ensure continuity of process and support systems through major initiatives (e.g. integration, divestiture, or reorganization); serve/lead program teams or sub-teams, manage interim state of operations, ensure establishment of defined future state of processes, as applicable

Maintain awareness of Culture of Excellence across BMS

Ensure processes are globally designed and deployed in an effective and inclusive manner where extensive iterative process design development, training and sustaining of processes are required.

IT System Support

Support development, approval, and execution of business case approval for improvement projects

Serve on systems project teams and committees to ensure that all system issues and opportunities are accommodated in a timely, effective, and Right First Time manner

Degree/Certification/Licensure

Bachelors or Masters Degree within life sciences or equivalent

Experience

Minimum of 6-8 years of clinical operations experience

Mastery of relevant Quality compliance processes and regulations, e.g. Good Clinical Practices (GCP)

Thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality and serious breach investigations

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 innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities

Experience with partner management

Understanding of clinical development

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 the resources to pursue their goals, both at work and in their personal lives.