Global Process Lead: Audits and Inspections
Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: May 16, 2022
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Job Description:
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.Overall responsibilities In
close collaboration with the Global Process Owner, serve as the
process lead for the Audits and Inspections processes ensuring they
remain in a state of control and are both effective and efficient
Supporting the Audits and Inspections process architectures of the
integrated Quality Management System (QMS), lead process
workstreams designed to monitor and improve the 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 for Audits and Inspections. 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 Audits and
Inspections program delivery, broker the delivery of these 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
clear and actionable decisions Participate/lead regulatory
surveillance and benchmarking initiatives with peers externally to
stay abreast of changes in regulations that affect Audits and
Inspections and other 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 functionalityDevelop, Deploy, and Maintain
Assigned Processes Maintain Audits and Inspections 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 these global process by close cooperation with relevant
functions and site/country leads Provide training, support, and
coaching as required Define Community of Practices (COPs),
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 applicable
COPs including both the technical processes and the behaviors
necessary to optimize Audits and Inspections 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 GPLs 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
forumsContinuous Process Improvement Utilize metrics and COP
operating mechanisms to identify and prioritize Audits and
Inspections and other Quality 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 GPLs 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 initiatives across BMS (e.g.
Inspection Excellence) Required Travel up to 25% for select global
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 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 mannerEducation: Minimum of
a Bachelor degree in a Natural Science, Pharmacy, or other
Healthcare-related field (Advanced Degree
preferred).Experience/Knowledge: A minimum of 10 years of
experience in Biopharm/Pharmaceutical industry with
cross-functional experience in one or more areas (i.e., research,
analytical, quality, engineering, manufacturing, regulatory CMC, or
IT) Knowledgeable of GxP regulations and expectations for core
health agencies; thorough understanding of regulatory requirements
in relation to Audit and Inspections Familiar with electronic
quality system tools Strong program and project management
experience with proven track-record of managing cross-functional
programs and ability to manage multiple, simultaneous projects
Familiarity with developing and executing organizational change,
including change management strategy and planning Ability to set
priorities and deliver results without constant feedback/input from
manager Ability to identify, manage, and/or escalate issues and
risks to timelines Ability to influence, initiate, and manage
changeSkills: 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 Ability to communicate with presence and influence in
both formal and informal settings, preparing and presenting
persuasive written and verbal materials with employees and
management at all levels 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
Demonstrated innovation, flexibility, open-mindedness, and
adaptability to meet objectives in a rapidly changing environment
with shifting prioritiesAround 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.Physical presence at the BMS worksite or physical presence in
the field is an essential job function of this role which the
Company deems critical to collaboration, innovation, productivity,
employee well-being and engagement, and enhances the Company
culture.To protect the safety of our workforce, customers, patients
and communities, the policy of the Company requires all employees
and workers in the U.S. and Puerto Rico to be fully vaccinated
against COVID-19, unless they have received an exception based on
an approved request for a medical or religious reasonable
accommodation. Therefore, all BMS applicants seeking a role located
in the U.S. and Puerto Rico must confirm that they have already
received or are willing to receive the full COVID-19 vaccination by
their start date as a qualification of the role and condition of
employment. This requirement is subject to state and local law
restrictions and may not be applicable to employees working in
certain jurisdictions such as Montana. This requirement is also
subject to discussions with collective bargaining representatives
in the U.S.Our company is committed to ensuring that people with
disabilities can excel through a transparent recruitment process,
reasonable workplace adjustments and ongoing support in their
roles. Applicants can request an approval of accommodation prior to
accepting a job offer. If you require reasonable accommodation in
completing this application or if you are applying to a role based
in the U.S. or Puerto Rico and you believe that you are unable to
receive a COVID-19 vaccine due to a medical condition or sincerely
held religious belief, during or any part of the recruitment
process, please direct your inquiries to . Visit careers.bms.....
click apply for full job details
Keywords: Bristol Myers Squibb, New Brunswick , Global Process Lead: Audits and Inspections, Other , New Brunswick, New Jersey
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