Manager QMS Systems
Company: Takeda Pharmaceutical
Location: New York
Posted on: January 27, 2023
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- Provide support to the GRA organization on the training
identification, assessment and administration for QMS systems.
- Provide leadership and QMS Training Systems operational
expertise in the identification, creation, and execution of GRA
Compliance QMS initiatives to drive overall compliance and growth,
while meeting Takeda corporate objectives.
- Partner effectively with cross functional teams, in the
proactive identification of key regulatory compliance QMS training
issues with the ability to determine actionable project proposals
and drive them to successful resolution.
- Provide GRA QMS expertise in the development and maintenance of
key compliance activities (e.g. training, documentation, and
deviations/CAPA as appropriate)
- Provide data to in support of the GRA training metrics program
and communication to organization with an eye on risk, trends, and
remediation recommendations/actions. ACCOUNTABILITIES:
- Support the GRA QMS training key elements (Deviations, CAPA and
Change Control) partnering with the GRA SMEs to ensure the timely
and successful completion.
- Drive GRA QMS training initiatives and implementation
strategies with alignment to stakeholders which may include Takeda
Global Quality, R&D Quality and Global Regulatory Affairs
- Evaluate, develop and effectively communicate to key
stakeholders GRA Compliance QMS training project and program
results, identification of potential regulatory risks, and risk
- Manage compliance training cross functionally, GRA functional
teams and Takeda 3rd party contractors, as necessary, in the
execution of QMS project plans, deliverables and implementation of
resolutions to ensure compliant GRA processes.
- Interact with all levels of GRA Management to present risks,
strategies troubleshoot and remediation for compliance training
- Provide GRA QMS training systems and process guidance aligned
with overall governance activities within GRA, and across R&D
and Global Quality.
- Identify and inform GRA QMS training process best practices
into the Takeda/GRA business processes to ensure delivery aligned
with company initiatives and expectations.
- Develop and sustain strong partnerships with cross functional
leadership and third parties to optimize delivery of GRA QMS
programs and projects ensuring alignment to R&D metrics
outputs, driving accuracy.
- Lead and engage in efforts to simplify and optimize GRA QMS
training processes, systems, and platforms to drive organizational
alignment and growth. EDUCATION, BEHAVIOURAL COMPETENCIES AND
- Bachelor's Degree or equivalent years (5-7+) of relevant
- 5+ years of experience in Pharmaceutical industry, preferring
regulatory affairs, research and development, quality
- Strong GxP systems knowledge (LMS, DMS, CAPA/Deviations) such
as Success Factors, Veeva Vault, and Trackwise
- Strong understanding of metrics, risk analysis, tracking and
trending of compliance activities.
- Ability to identify proactively and anticipate risk of
non-compliance in a complex environment.
- Demonstrated knowledge of global health authorities,
regulations, product approval and lifecycle processes for major
markets, quality pharmaceutical and regulatory affairs requirements
- Practical operational experience working across disciplines
within a global environment.
- Experience working strategically within a global team and a
multi-cultural environment. Efficiently/actively manages conflict
in a tactful, diplomatic way, seeking effective solutions for all
- Able to manage both time and priority constraints and to manage
multiple priorities simultaneously.
- Capability to critically analyze complex and/or ambiguous
information and the impact on process to effectively communicate
complex issues both verbally and in writing.
- Excellent analytical, technical and problem-solving skills
- Strong communication skills with the ability to express ideas
clearly and concisely to a variety of audiences.
- Ability to understand/analyze/synthesize and communicate to
- Must be able to lead as part of a global team, and deliver
results in a matrix organization.
- Strong project management capabilities. EEO Statement
Takeda is proud in its commitment to creating a diverse workforce
and providing equal employment opportunities to all employees and
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, gender expression,
parental status, national origin, age, disability, citizenship
status, genetic information or characteristics, marital status,
status as a Vietnam era veteran, special disabled veteran, or other
protected veteran in accordance with applicable federal, state and
local laws, and any other characteristic protected by law.
Keywords: Takeda Pharmaceutical, New York , Manager QMS Systems, Executive , New York, New York
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