Senior Manager, ITQM HA Inspection Support
Company: Bristol Myers Squibb
Location: Princeton
Posted on: June 25, 2022
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.Responsibilities
- Lead the health authority inspection support end-to-end process
for IT
- Facilitate inspection readiness, requests for
information/documentation, and inspection response activities in
support of internal and external health authority commitments
- Partner with IT subject matter experts to ensure that process
and system overviews are developed and maintained in support of
inspection interactions
- Provide continuous awareness to IT personnel on inspection
related matters
- Lead the creation and dissemination of GxP inspection education
and awareness content with evolving regulatory expectations
- Advise the overall IT risk management process of inspection
related risks/mitigations as required
- Collaborate with ITQM, IT, business users and internal Global
Quality compliance team to ensure that inspection activities are
efficient, consistent, and compliant with external regulations and
internal procedures
- Other specific responsibilities as assigned by the
supervisorSkills & Requirements:
- Extensive knowledge and experience of inspection management
policies, processes, and protocols with ability to drive inspection
preparedness and response actions.
- Thorough knowledge and understanding of the current regulatory
expectations.
- Experience leading and driving multidisciplinary work groups or
teams to meet objective across multiple inspection activities.
- Pharmaceutical background preferred. Understanding of the
health authority regulations (e.g., 21 CFR Part 11 / Annex 11, Data
Integrity) and statutory requirements.
- Must have proven ability to realign subject matter resources
rapidly to meet changing inspection requirements and regulatory
expectations.
- Bachelor's degree in any related discipline.
- 5+ years of experience in IT / quality & compliance activities
including audit and inspection support; 3+ years of experience in
FDA regulated industry or equivalent; 2+ years of end-to-end
process ownership and management experience.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.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 adastaffingsupport@bms.com. Visit
careers.bms.com/eeo-accessibility to access our complete Equal
Employment Opportunity statement.Any data processed in connection
with role applications will be treated in accordance with
applicable data privacy policies and regulations.
Keywords: Bristol Myers Squibb, Trenton , Senior Manager, ITQM HA Inspection Support, Executive , Princeton, New Jersey
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