Job Description

Job Description

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 rich in diversity. 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: careers.bms.com/working-with-us

The Global Process Lead (GPL) for Commercial Change Management (CCM) will ensure the Commercial process remains in a state of control and is both effective and efficient serving as the key point of contact for CCM providing customer-based cross functional support.

Key Responsibilities:

Drive ongoing process optimization and improvement following standard methodology.

Develop and maintain global processes, procedural document, 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.

Participate (or lead when delegated) in regulatory surveillance and benchmarking initiatives with peers internally and 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.

Work with the Global Process Owner (GPO) and LPO’s (Local Process Leads) to define process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms including both product/clinical trial quality and process effectiveness aspects.

Regularly review process performance and effectiveness of the Commercial Change Management process and provide feedback to the GPO and CCM Community of Practice (CoP) for action and remediation.

Identify and prioritize continuous improvement opportunities for the process.

Lead problem solving and continuous improvement efforts working effectively across the matrix by engaging with the broader process owner network, local site or function process owners (LPOs), and Subject Matter Experts (SME) in designing and deploying QMS process improvements. 

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 and ensure establishment of defined future state of processes, as applicable).

Provide training, support, and coaching as required to support deployment of the global CCM Process.

Key Requirements:

A minimum of a Bachelor’s degree preferably in Life Sciences

A minimum of 10 years’ experience in biological sciences or equivalent

A minimum of 8 years’ experience and in-depth knowledge of managing/performing GxP change management activities

Strong understanding of cGxPs and in-depth knowledge of quality systems principles and applications

In depth experience in change management processes and the regulations governing change management

Cross-functional experience including experience in Pharmaceutical or BioPharma manufacturing operations

Demonstrated influential leadership expertise and experience with senior level interactions

Capability to build alignment with business partners including research & development, commercial operations and manufacturing regional and site leaders

Enterprise mindset to be able to think and act across functions and divisions

Demonstrated change agility in anticipating and leading others through change and ambiguity

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 and effectively communicate challenging goals and objective

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