Astellas Pharma CMO QA Manager in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a CMO QA Manager opportunity in Northbrook, IL.
Purpose & Scope:
Responsible for managing the cGMP Quality Assurance requirements for drug substances, intermediates, and in-process and finished drug products manufactured for Astellas by third party Contract Manufacturing Organizations (CMOs). Manages the QA batch record review and disposition for distribution processes as well as the quality control specifications for Astellas commercial products. Manages the following quality systems that have been established to maintain compliant commercial products: Deviations, Change Control, Risk Evaluation, Management Review Board, Stability, Annual Product Review, and Supplier Evaluation, Quality Business Review Meetings.
Essential Job Responsibilities:
Manages the batch record review and QA disposition process for Astellas commercial drug substances, intermediates, and in-process and finished drug products in conjunction with third party logistics firms (3PLs) using Astellas specifications and procedures. Ensures timely release of product and facilitates the resolution of all deviations, non-conformances and other batch related quality issues.
Manages the Astellas quality control specifications and requirements to assure that drug substances, intermediates, and in-process and finished drug products manufactured for Astellas conform to contracted requirements.
Conducts cGMP audits of suppliers in support of the supplier evaluation program as required. Develops and distributes formal reports in a collaborative manner. Cooperates with Supply Chain, Purchasing, and Quality Systems groups to maintain a list of approved suppliers.
Conducts and coordinates QA assessments of REC, Change Controls, Field Alerts, Product Stability, Supplier Review, Annual Product Review, and other assessments as assigned. Maintains related records and tracking systems. Review and Compilation of product and process change requests for respective product AR's.
Identifies major cGMP compliance issues and prepares formal corrective action plans to be approved by management. Demonstrates prudent independent judgment to balance quality expectations and other stakeholder needs.
Provide support for Quality Systems in during regulatory or business partner audits. Prepare, maintain and organize audit request items as required.
Assures Astellas and CMO compliance with corporate policies, Global Procedures and Guidelines, SOPs and regulatory agency standards. Identifies issues and initiates corrective action as required.
Assists in the coordination of recalls, field alerts and regulatory agency inspections as necessary.
Collaborates with departmental and cross-functional teams to address cGMP compliance issues and completes projects as assigned. Develops and maintains effective relationships with internal and external stakeholders which may include regional and global Astellas entities. QA representative on Astellas and Global project teams as directed. Participates in working teams to provide direction regarding quality and compliance and Astellas QA department requirements as needed.
Authors, revises, and performs maintenance and administration of departmental controlled documents (i.e., SOPs, WPDs, Forms, etc.) as necessary.
This position is primarily responsible for managing the Quality Assurance requirements for drug substances, intermediates, and in-process and finished drug products manufactured for Astellas by third party Contract Manufacturing Organizations. Responsible for batch documentation review and approval, batch release, change control and Deviation management.
This position is an individual contributor reporting to the Associate Director, CMO QA GQAA.
BA / BS required.
Seven (7) years of industry experience and three (3) years of QA experience.
In depth knowledge of cGMP and other regulations as required with a broad knowledge of quality principles and industry trends.
Ability to apply industry knowledge and interpretation to anticipate impact to stakeholders relating to batch record review and product disposition, supplier audit, and risk management.
Effective written and oral communication, interpersonal skills, facilitation and influencing skills with an ability to effectively work across the Astellas group and external stakeholders.
cGMP auditing experience required and experience in a pharmaceutical manufacturing environment desired. Must be able to represent the company to external stakeholders during supplier audits.
Develops approach for managing one or more areas of responsibility. Executes quality strategy with management guidance. Requires minimal management oversight. Primarily self-directed.
Previous experience in pharmaceutical Quality Assurance and previous experience in a GMP pharmaceutical manufacturing plant.
Science degree preferred.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Quality Operations