Process Lead QMS Document Management

Profile

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.

PRINCIPLE OBJECTIVE OF POSITION

The purpose of this role is to ensure consistent global leadership for the Document Management process in the GxP Quality Management System Framework. The 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 Document Management process. 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 process metrics to achieve Quality Outcomes that ultimately drives continuous improvement working across the matrix in a Community of Practice fashion with Local Process Owners (LPO), other Process Leads (PL), and Subject Matter Experts (SME).

The PL role reports into the 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 the Document Management 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


60%-Develop, Deploy, and Maintain Assigned Process:


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

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

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

Required Travel 40 to 50% for select process lead roles 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 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


EDUCATION


Minimum of a Bachelor degree in a Natural Science, Pharmacy, or other Healthcare-related field

Minimum 10 years of experience in pharmaceutical industry


EXPERIENCE & KNOWLEDGE


Minimum of 8 years of pharmaceutical industry experience with diverse quality and/or compliance discipline.

Demonstrated knowledge in quality and/or compliance discipline with in depth knowledge of Quality Systems across different GxP areas and global health authority regulations inclusive of GLP, GCP, GPvP, GMP and GDP

Familiar with electronic quality system tools

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

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

Understanding of quality systems related to management responsibilities, training and qualification, event management, change and document management, and quality risk management across GxP areas


SKILLS & COMPETENCIES


Demonstrated influential leadership expertise and experience with senior level interactions

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


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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Sign Up Now - WashingtondcCrossing.com