Astellas Pharma Associate Manager, GDP Quality Assurance in Northbrook, Illinois
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 platform.
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 manner.
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 stakeholders.
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 positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Quality Assurance/Quality Control
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans