Manager, QA Systems

Overview

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

Purpose

The Manager, Quality Assurance Systems, will provide Quality oversight to Astellas Gene Therapies (AGT) of the transition and continual improvement of the AGT Quality Management System (QMS) Change Management (CM) program. This position will own the Change Management program, to include (but not be limited to) ensuring inspection readiness of Change Management, QA oversight of Change Management improvement projects for AGT, CM Quality metrics and other aspects related to QA oversight required to support GMP manufacturing operations.

This position will be located in Sanford, NC reporting directly to the Lead, Quality Systems and Compliance. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures.

• Execute daily program level responsibilities, including development and implementation of processes and continuous improvements to ensure productivity and alignment with departmental/site/global goals.
• Establish and foster a cGMP quality culture that prepares the site for regulatory pre-approval inspections and eventual licensure for commercial manufacturing.
• Provide support to Manufacturing, Facilities, Supply Chain, and other supporting function change management owners and assessors, reviewers, and approvers to ensure compliant documents/records.
• Build relationships with key counterparts and stakeholders across campuses to establish aligned QA change management program and related processes that meet both regulatory guidance and company policies.
• Partner with area leadership to develop and provide instruction for site-level training curricula program to owners, reviewers and approvers of GxP change records/actions.
• Track and resolve emerging inspection readiness gaps; develop remediation plans to mitigate compliance risks to assure that regulatory and quality requirements have been met.
• Participate and represent the company in regulatory (e.g., FDA, EMA, DHHS, etc.) inspections and audit activities conducted by third-party and corporate partners as quality process owner for change management programs.
• Establish and maintain expert knowledge of change management regulatory requirements in accordance with applicable FDA Regulations, Eudra Lex and ICH Guidance, as well as other applicable regulatory requirements applicable to the organization, continuously review guidance publications for industry and upcoming changes to regulations for QMS.
• Effectively communicate changes to the change management program requirements, to functional groups ensuring understanding and implementation of required actions, and overall compliance.
• Facilitate cross functional team discussions or assessments in support of major/critical changes, not limited to implementation of GxP processes, product, equipment, etc.
• Own the Change Management (CM) Program including CM policies/procedure, work instruction, forums and continuous improvement for AGT.
• Ensure alignment of AGT Quality Management Systems to Astellas Quality Management Systems.
• Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Examines use of QMS to create efficiencies in practices.
• Effectively drive results and effectively network and communicate…