Senior Manager, Global Quality GxP Data Integrity SME
Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: May 8, 2022
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.Governance program through
remediation activities and is accountable to maintain an
enterprise-wide Data Integrity Governance system to ensure that
regulatory and BMS requirements are addressed thoroughly and
effectively in a timely manner. Communicate data integrity
training/communication regarding data integrity principles to all
levels of people in the organization. Also accountable for
supporting other Quality Programs as assigned.Principal Objective
of the PositionProvide GxP subject matter expertise to support an
effective and knowledgeable GxP Data Integrity Governance tower
within the Global Quality GxP Data Integrity organization with a
focus on remediation activities being performed at the sites and
functions. Accountable to help establish and maintain an end-to-end
(GPS and R&D) Data Integrity Governance program to ensure that
regulatory and BMS requirements are addressed thoroughly and
effectively in a timely manner. Additionally, may support oversight
for the management of electronic records and/or electronic
signatures in compliance with worldwide health authority
regulations.Key Responsibilities and Major Duties
- In conjunction and at the direction of the Associate Director
of the GxP Data Integrity Program, provide day to day support for
the governance, management, and coordination of activities related
to the Data Integrity Governance Program including implementing and
maintaining Data Integrity compliance activities across the
end-to-end product lifecycle (GPS and R&D) and across all BMS
sites and internal functions in alignment with relevant
governmental regulations and guidelines.
- Responsible for developing, reviewing, and approving
appropriate BMS policies and procedures and coordinating all
relevant activities between Quality, IT and other departments in
relation to implementation, maintenance and change management of
- Support and manage remediation efforts across the network,
utilizing QRM based principles to identify risk and establish
- Provide active support during regulatory agency and third party
inspections.Support and conduct data integrity progress meetings
across the network. This may include leading/supporting specific
site/organizational group data integrity assessments and
remediations as applicable.General Activities
- Develop and utilize metrics and KPIs to assure program success
and data integrity remediation progress.
- Assist in conducting data integrity gap assessments, developing
remediation plans and strategies, and managing tasks to
- Ensure compliance with all Company policies and procedures,
including safety rules and regulations.
- Support the development of standardized tools and
- Benchmark within and outside of the Company, including
regulatory agencies, business partners and suppliers.
- Support the various audit program across and within departments
around data integrity concepts and training.
- Adherence to BMS core behaviors.Experience Requirements
- University Graduate; Life-Sciences degree preferred.
- A minimum of 6 years of experience in the pharmaceutical
- A minimum of 4 years of experience and in-depth knowledge of
Data Integrity requirements.
- A minimum of 2 years of experience and in-depth knowledge of
GxP computer system validation (CSV) and Part 11 requirements.Key
- Cross-functional experience in three or more areas (i.e.
Research, Analytical/QC, QA, Engineering, Manufacturing,
Pharmacoviligance, Clinical, Regulatory, IT etc.) is desired.
- Knowledge and experience in the GxPs.
- Experience with senior level interactions and influence with
Manufacturing Operations, Regulatory, R&D, Medical and Clinical
- Experience in Pharmaceutical or Biotech manufacturing
- Experience in working in the matrix and challenging self and
others to continuously learn and improve.
- Ability to collaborate and lead cross-functionally to help
drive continuous improvement and promote knowledge sharing and
endorsement of best practices across sites.
- Provide subject matter expertise in regulatory requirements,
expectations, specifications/methods/compendia, manufacturing
technology, and/or quality assurance is required.
- Ability to build alignment with business partners including
research & development, commercial operations and manufacturing
regional and site leaders.
- Ability to demonstrate strong project management focus as well
as focus on execution of strategic decisions while balance
- Demonstrate the ability to influence areas not under direct
control to achieve objectives and effectively communicate
challenging goals & objectives.
- Demonstrate strong leadership capability with ability to make
and act on decisions while balancing speed, quality and risk.
- Ability to work in a matrix environment and build strong
relationships by being transparent, reliable and delivering on
- Ability to provide innovative ideas to improve quality and
compliance that create value including seeking new information and
- Good understanding of the drug and device development process
from discovery through to regulatory filing and approval of drug
applications as well as commercial manufacturing processes.
- Must understand industry accepted software development and
validation life cycle programs.
- Excellent interpersonal skills, including written and verbal
- Strong sense of ethics, diplomacy and discretion.
- Commitment to Quality.
- Strong critical thinking to analyze complex situations and
discern critical issues.
- Able to work effectively with multicultural workforce.
- Excellent team player attitude.
- Ability to manage competing priorities.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 firstname.lastname@example.org. 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, New Brunswick , Senior Manager, Global Quality GxP Data Integrity SME, Executive , New Brunswick, New Jersey
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