Associate Manager, GDP Quality Assurance
Posted on: June 19, 2022
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:
Acts as the primary QA responsible for Storage and Distribution
activities related to commercial products. Provides support for
daily activities between Astellas, external third-party logistics
providers and Astellas Serialization Team to ensure effective
quality systems that meet GMP, GDP, and established Astellas
requirements. Manages the documentation and filing of batch
documents to maintain traceability and compliance of Astellas Group
drug products. Prioritizes QA release activities related to
commercial products based on risk.
Essential Job Responsibilities:
* Independently provides daily QA oversight to Product Storage and
Distribution activities to third party logistics (3PL) providers.
Responsible for the development, review and revision of Astellas
specific Work Instructions at 3PL providers. Communicate the
requirements of Astellas US commercial product Supply Chain in
order to maintain established good distribution practices.
* Coordinates and manages the document control and filing of
distribution release documents generated between CMO (contract
manufacturing organizations), Astellas group manufacturing plants
and third-party logistics providers. Utilize document control tools
to properly maintain and track documents within the technology
* Coordinates Astellas QA Serialization activities for batch
distribution, incident management, root cause identification and
documentation of investigation events.
* Reviews and documents transportation deviations, damage reports,
product returns and stock discrepancies for products moving in the
US Commercial Product Supply Chain. Independently escalates issues
to CMO group for Supplier Complaint and investigation and documents
supplier complaints in Astellas Deviation management system.
* Independently leads and provides support to quarterly business
review required QA activities by at the 3PL providers by preparing
QA materials, documenting and issuing the results of the meetings,
and following up on outstanding quality assurance items in a timely
* Provides QA support to IT Validation testing scripts and system
testing using SAP tools.
* Utilizes tools to track and trend batch distribution activities
for contract manufacturing organizations and Astellas group
manufacturing plants and ensures that Astellas systems.
This position is primarily responsible for supporting the Storage
and Distribution activities related to commercial products at third
party logistics providers. Responsible for managing the controlled
documentation generated by product transportation throughout the
commercial supply chain in the US.
This position is an individual contributor performing many
independent activities reporting to the Sr. Manager, Associate
Director or Director, GDP QA in Quality Operations.
* Minimum Bachelor's Degree with a minimum of 3 years of industry
experience and some QA/QC experience.
* Knowledge of cGMPs and other industry regulations.
* Effective written and oral communication and interpersonal
skills, facilitation and influencing skills with an ability to
effectively work across the Astellas group and external
* Ability to represent the company to external stakeholders.
* Strong commitment to organization and document management.
* Ability to apply industry knowledge and interpretation to
anticipate global impact and contribute ideas for strategies and
levels of management. Ability to develop and maintain effective
relationships with internal and external stakeholders including
Global Astellas entities.
* Can develop / execute quality strategies with management
guidance. Makes decisions for the department in their area of
quality expertise with management oversight.
* Science degree preferred.
* Previous experience in a Distribution Quality role.
* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time,
plus national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible
* Long Term Incentive Plan for eligible positions
* Referral bonus program
Equal Opportunity Employer Minorities/Women/Protected
Keywords: Astellas, Arlington Heights , Associate Manager, GDP Quality Assurance, Executive , Deerfield, Illinois
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