Quality Risk Management (QRM) 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.

The purpose of this role is to ensure consistent global leadership for key Quality Risk Management processes within the GxPs (GMP, GDP, GLP) for biologics, small molecules, and devices. The QRM Process Lead (PL) is accountable to drive initial process optimization and improvement following standard methodology, to ensure resources are identified and aligned at the team-level to drive process optimization activities, and lead optimization to align with the GxP document hierarchy. This will include serving as the key point of contact for Quality Risk Management. The PL will ensure role definition and clarity on key accountabilities for process steps through an enterprise lens and ensure that process interdependencies are understood and optimized. In addition, the PL will establish, track, and trend QRM process metrics to achieve Quality Outcomes that ultimately drives continuous improvement. This role will work across the matrix and also be responsible for establishing a community of practice in QRM with Local Process Owners (LPO) and Subject Matter Experts (SME).

The QRM PL role reports into the QRM Global Process Owner (GPO) who is accountable to provide high-level oversight, set strategy for the process and ultimate decision making in optimizing and the ongoing sustainability of the process.

Overall responsibilities

• In close collaboration with the Global Process Owner, serve as the process lead for QRM (GMP, GDP, GLP) 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 work stream 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

60%-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 for QRM by close cooperation with relevant functions and site/country leads

• Provide training, support, and coaching as required

• Define QRM 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

• Define process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms including both product quality and process effectiveness aspects

• Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses

• Collaborate with other PLs and SMEs to drive optimal execution of process across BMS and external partners

• Support or manage high-priority, cross-functional events

• Maintains global expertise through ongoing training and participation in industry forums

30%-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

• Some travel may be required, up to 30% to 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.

10%-IT System Support

• Support the development, execution or the review and approval of business cases for continuous improvement projects in QRM

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

Education:

• Bachelor's degree in a scientific related discipline, such as: Pharmaceutical Science, Engineering, Risk Management or another related science

• 10 plus years broad experience in Pharmaceutical or a related regulated industry. Valid operational experience includes risk management, R&D, quality operations, manufacturing or other relevant experience working at a regulatory health authority

• Master's Degree and/or PMP certification considered a plus

Experience/Knowledge:

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

• Extensive knowledge and experience in risk management tools and techniques (including, but not limited to: FMEA, FMECA, FTA, PRA)

• Strong program and project management experience with proven track-record of several years managing cross-functional programs and ability to manage multiple, simultaneous projects, preferably in Quality

• Direct experience leading and supporting risk management activities in a pharmaceutical, medical device, or related regulated industry Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities

• Experience with partner/alliance management

• Understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, statistical methods, regulatory and quality control/quality assurance processes

• Must have a comprehensive understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), regulations and guidances (ICH, CFR, PIC/S, etc.) as related to Pharmaceutical and Biotech Manufacturing & Development

• Strong analytical and problem solving skills

Skills/Competencies:

• Demonstrated influential leadership expertise and experience with senior level interactions and influence with Device Operations, Product Development, Manufacturing and Global Quality

• 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 and effectively communicate challenging goals and 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 (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)

• 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 to deliver value added business results that meet high quality requirements with tight deadlines

• 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

Development Value:

• Develop Enterprise mindset and ability to navigate cross-functionally

• Pre-requisite for promotion

• Develop subject matter expertise in various GxP process areas

• Develop continuous improvement mindset

• Develop leadership and communication capabilities

• Gain responsibility for operational improvements

• Gain exposure to executives across different functions

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.