Associate Director, Engineering and Validation Global Process Lead

Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: February 17, 2021

Job Description:

Associate Director, Engineering and Validation Global Process Lead New Brunswick - NJ - US Phoenix - AZ - US At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.--In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. The Global Process Lead (GPL) 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 role will serve as a key point of contact for the following global processes: Equipment Design, Equipment Qualification, and Cleaning Validation. The GPL 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 GPL 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). This role reports into the Global Process Owner (GPO) of Equipment Design & Qualification and reports dotted-line into the GPO for Cleaning Validation. Major Duties and Responsibilities:

• In close collaboration with the Global Process Owner, serve as the process lead for QMS processes (process equipment design, qualification, cleaning validation) ensuring it remains in a state of control and is both effective and efficient.
• As GPL will be the long term principal corporate Quality owner for managing the sustainability of the three QMS processes (process equipment design, qualification, cleaning validation), across the global network of BMS.
• 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 (60%):
  • 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.
  • 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. Continuous Process Improvement (30%):
    • 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. IT System Support (10%):
      • 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. Required Knowledge/Skills/Qualifications Education:
        • Minimum of a Bachelor degree in Chemical or Mechanical Engineering.
        • Minimum of 15 years experience in biopharma industry in concentrated disciplines of: Manufacturing, Engineering, Validation, Plant Design, and/or Quality. Experience and 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 GMP/GLP processes
            • Extensive work experience with GMP activities of: design, qualification, and validation of process equipment.
            • Expertise in cleaning validation within biopharma manufacturing.
            • Extensive work experience in managing the lifecycle of process equipment: specifications, design, safety, fabrication, FAT, SAT, CQV, start-up, equipment robustness, knowledge management.
            • Experience with electronic validation software platforms (e.g. ValGenesis) is a plus.
            • 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). Skills and Competencies
              • Demonstrated influential leadership expertise and experience with senior level interactions and influence with Manufacturing, Engineering, 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. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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. W e're creatinginnovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Keywords: Bristol-Myers Squibb, New Brunswick , Associate Director, Engineering and Validation Global Process Lead, Executive , New Brunswick, New Jersey