Bristol-Myers Squibb Company

Quality Management System Process Lead - Deviations & CAPA

Location
New Brunswick, NJ, United States
Posted
Aug 09, 2019
Ref
R1516683
Required Education
Bachelors Degree
Position Type
Full time
The purpose of this role is to ensure consistent global leadership for key Quality processes, including but not limited to one or more processes in the Quality Management System Process Architecture. 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 assigned process(es). The PL will ensure role definition and clarity on key accountabilities for process steps through an enterprise lens and ensure that process interdepencies 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. The GPO will serve as executive oversight and primary decision-maker including budgetary decisions for assigned processes. The GPO will provide decisions required and oversight to Process Leads (PL) including resolution of escalated issues, endorse and monitor metrics to achieve Quality Outcomes, and support Community of Practice.

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


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 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 degreein a Natural Science, Pharmacy, or other Healthcare-related field
  • Master's Degree and/or PMP certification with 10 plus years experience in pharmaceutical industry in concentrated disciplines of R&D, Operations, Validation, and/or Quality preferred


Experience/Knowledge:

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


Specific to relevant GCP processes
  • Understanding of clinical development
  • Mastery of relevant Quality compliance processes and regulations, e.g. Good Clinical Practices (GCP)
  • A minimum of 5-7 years of clinical operations, regulatory, pharmacovigilance, or other relevant biopharmaceutical industry experience


Specific to relevant GMP/GLP processes
  • Understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes
  • Mastery of relevant Quality compliance processes and regulations, e.g. Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)
  • A minimum of 10 years of experience in quality operations
  • A minimum of 12-15 years of experience in pharmaceutical operations


Skills/Competencies:
  • Demonstrated influential leadership expertise and experience with senior level interactions and influence with R&D/GPS functional areas 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