Senior Manager Clinical Quality Assurance (GCP)
Company: Astellas
Location: Northbrook
Posted on: May 28, 2023
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Job Description:
Do you want to be part of an inclusive team that works to
develop innovative therapies for patients? Every day, we are driven
to develop and deliver innovative and effective new medicines to
patients and physicians. If you want to be part of this exciting
work, you belong at Astellas! Astellas Pharma Inc. is a
pharmaceutical company conducting business in more than 70
countries around the world. We are committed to turning innovative
science into medical solutions that bring value and hope to
patients and their families. Keeping our focus on addressing unmet
medical needs and conducting our business with ethics and integrity
enables us to improve the health of people throughout the world.
For more information on Astellas, please visit our website at
www.astellas.com. This position is based in Northbrook, Illinois.
Remote work from certain states may be permitted in accordance with
Astellas' Responsible Flexibility Guidelines. Candidates interested
in remote work are encouraged to apply. Purpose and Scope:The ideal
candidate will be responsible for the development and maintenance
of excellence in Clinical Quality Assurance activities for Astellas
sponsored programs. This position works in partnership with Medical
and Development and other business units in support of global and
local drug development, registration and marketing for assigned
projects across Therapeutic Areas for all stages of drug
development. Essential Job Responsibilities:Responsible for the
management of multiple regional, cross regional and/or global
audits. This includes the independently scheduling, scoping
definition, planning, conducting and reporting of audits, liaising
with stakeholders on audit findings and the follow up thereof. It
also incorporates interpretation of findings, providing trending
information, root cause analyses and identifying lessons learned
for the continuous improvement of the Astellas organization.
Manages and follows up on findings and improvement areas.
Responsible for providing unsupervised Good Clinical Practice
expert advice to key personnel. This includes and is not limited
to:Developing training materials and providing Good Clinical
Practice training internally and externally to both small and large
professional organizations. It also encompasses coaching of
Clinical Quality Assurance colleagues and other functions on
Clinical Quality Assurance related processesIn case of regulatory
agency inspections, review of responses from operations before
sending to Clinical Quality Assurance management for their final
review and approvalInterpreting regulatory authorities'
requirements and advising in the implementation across the Astellas
organization.Responsible for regulatory inspection preparation at
Astellas entities and/or partners across the region and globally.
Analyzes the risks, defines the strategy for inspection readiness
and manages the rollout of the inspection readiness program across
departments and territories, ensuring a harmonized approach.
Responsible for identifying outsourcing needs, selecting, managing
and evaluating 3rd party QA service providers of which audit and/or
consultancy activities have been outsourced. This includes
providing training, managing financial information and maintaining
effective interfaces to ensure that outputs meet the defined
expectations in terms of quality, content and timelines. Supports
the development, improvement and maintenance of the Astellas
Quality System by identifying root causes to non-conformances
related to the processes and/or systems, and by addressing observed
gaps in these processes and systems. This includes research of the
Pharma Market Place / Quality Assurance organizations, Regulatory
developments and Inspection reports to ensure Astellas meets its
strategic objectives in terms of Quality, Business Model and
Effectiveness. Manages or supports Good Clinical Practice
inspections. This includes communication with Regulatory
Authorities, Inspection preparation, inspection hosting, support of
corrective and Preventive Action generation and monitoring of
follow up to ensure that any risk / nonconformance as identified by
inspectors/investigators is adequately addressed and mitigated
Develops and manages interfaces with Quality Assurance departments
of service providers, to ensure Quality Assurance oversight of the
service provider and that any risk to Astellas business is being
mitigated Drives consistency across projects, processes and
organization by (not limited to):Leading process improvement and
operational excellence activities across Clinical Regulatory
Quality Assurance and Medical & Development functions.Supporting
and executing Due Diligence and/or post acquisition
activities.Enhancing stakeholder relationship to ensure compliance
and consistency of regulate activities and associated
processes.Driving trending and metrics across studies and Medical &
Development business
processes.PDN-9913223b-c855-46d8-a929-052b6befcdf6
Keywords: Astellas, Chicago , Senior Manager Clinical Quality Assurance (GCP), Executive , Northbrook, Illinois
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