Associate Director, Engineering and Validation Global Process Lead
Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: February 17, 2021
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
- 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
- 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
- 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
- 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
- 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
- Minimum of a Bachelor degree in Chemical or Mechanical
- Minimum of 15 years experience in biopharma industry in
concentrated disciplines of: Manufacturing, Engineering,
Validation, Plant Design, and/or Quality. Experience and Knowledge:
- Thorough understanding of company policies and regulatory
requirements, and their relation to the management and
documentation of product quality and serious breach
- 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
- 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
- Extensive work experience with GMP activities of: design,
qualification, and validation of process equipment.
- Expertise in cleaning validation within biopharma
- 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
- 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
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