Senior Director, Competitive Compliance (Corporate Quality)
Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: June 1, 2025
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Job Description:
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are
usually associated with a job. But working at Bristol Myers Squibb
is anything but usual. Here, uniquely interesting work happens
every day, in every department. From optimizing a production line
to the latest breakthroughs in cell therapy, this is work that
transforms the lives of patients, and the careers of those who do
it. You'll get the chance to grow and thrive through opportunities
uncommon in scale and scope, alongside high-achieving teams. Take
your career farther than you thought possible.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.
Read more: careers.bms.com/working-with-us .Position
SummaryReporting to the Vice President, Corporate Quality, this
role provides strategic and tactical direction for the GPS
divisional audit program for product development, clinical
supplies, manufacturing, and product distribution across all
modalities including CMOs, CLOs, material suppliers and service
providers, inclusive of IT systems and services. Leads inspectional
readiness activities across the network inclusive of biologics,
small molecule and cell therapy as well as distributors and local
markets inclusive of global regulatory agencies worldwide. Serves
as consultancy to sites/functions with regulatory inspections
including Pre-inspection readiness.Key Responsibilities -
Responsible for development of risk-based process for assessment of
sites, suppliers and contract providers across all modalities and
vendor types ensuring inspection readiness strategies and risk
mitigation across the enterprise. - Responsible for the execution
of strategic audit plan and identification of emerging risk. -
Development of Inspection Readiness strategy that provides
standardized end-to-end approach to inspection preparedness that
can be leveraged by the BMS network. - Collaborate to Identify
emerging internal and external compliance indicators to proactively
inform inspection readiness strategy. - Partners with business to
accommodate ad-hoc audits based on performance or changes in
business needs. - Responsible for management of risk-based audit
program across all modalities and vendor types. - Partners with
business units and functions to drive remediations of audit
outcomes with a lens towards enterprise performance and patient
supply. - Serves as consultancy to sites/functions with regulatory
inspections including pre-inspection readiness as well as
regulatory inspection responses for complex compliance matters. -
Assist with regulatory notifications, including assuring
appropriate and consistent standards are in place - Works closely
with legal to ensure robust and appropriate communications with
external regulators globally. - Support site and function teams
during regulatory inspections or audits, which may include direct
interface with inspectors/auditors and writing/reviewing responses.
- Continuous improvement across R&D and GPS quality metrics
defined by GxP requirements.Qualifications & Experience - Minimum
of a bachelor's degree in scientific discipline. - 15 plus years'
experience in the pharmaceutical industry. - Thorough understanding
of regulatory requirements across multiple modalities inclusive of
GMP, GDP and IT/Data Integrity Requirements. - Profound
understanding of international GxP regulations and policies setting
processes of major regulatory agencies (e.g., US FDA, EU, WHO). -
Quality operational experience to ensure understanding of key
business quality and compliance drivers of the Pharmaceutical
Industry. - Strong communication, negotiation, problem solving, and
interpersonal skills. - Demonstrated strong leadership capability
with ability to make and act on decisions while balancing speed,
quality and risk. - Demonstrated change agility and leading others
through change and ambiguity. - Ability to provide innovative ideas
or alternatives that create. - High organization awareness (e.g.,
interrelationship of departments, business priorities), including
significant experience working cross-functionally and in global
teams. - Demonstrated ability to work effectively in a matrix
environment and drive results through "influence" as well as direct
management. - Demonstrated Enterprise mindset to be able to think
and act across functions and divisions.GPS_2025#LI-HybridIf you
come across a role that intrigues you but doesn't perfectly line up
with your resume, we encourage you to apply anyway. You could be
one step away from work that will transform your life and
career.Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives
through science ", every BMS employee plays an integral role in
work that goes far beyond ordinary. Each of us is empowered to
apply our individual talents and unique perspectives in a
supportive culture, promoting global participation in clinical
trials, while our shared values of passion, innovation, urgency,
accountability, inclusion and integrity bring out the highest
potential of each of our colleagues.On-site ProtocolBMS has an
occupancy structure that determines where an employee is required
to conduct their work. This structure includes site-essential,
site-by-design, field-based and remote-by-design jobs. The
occupancy type that you are assigned is determined by the nature
and responsibilities of your role:Site-essential roles require 100%
of shifts onsite at your assigned facility. Site-by-design roles
may be eligible for a hybrid work model with at least 50% onsite at
your assigned facility. For these roles, onsite presence is
considered an essential job function and is critical to
collaboration, innovation, productivity, and a positive Company
culture. For field-based and remote-by-design roles the ability to
physically travel to visit customers, patients or business partners
and to attend meetings on behalf of BMS as directed is an essential
job function.BMS is dedicated to ensuring that people with
disabilities can excel through a transparent recruitment process,
reasonable workplace accommodations/adjustments and ongoing support
in their roles. Applicants can request a reasonable workplace
accommodation/adjustment prior to accepting a job offer. If you
require reasonable accommodations/adjustments in completing this
application, or in any part of the recruitment process, direct your
inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/
eeo -accessibility to access our complete Equal Employment
Opportunity statement.BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19
boosters.BMS will consider for employment qualified applicants with
arrest and conviction records, pursuant to applicable laws in your
area.If you live in or expect to work from Los Angeles County if
hired for this position, please visit this page for important
additional information:
https://careers.bms.com/california-residents/Any data processed in
connection with role applications will be treated in accordance
with applicable data privacy policies and regulations.
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Keywords: Bristol-Myers Squibb, Parsippany-Troy Hills Township , Senior Director, Competitive Compliance (Corporate Quality), Executive , New Brunswick, New Jersey
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