QA Manager, Quality Risk Management

QA Manager, Quality Risk Management

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.

The Role

The QA Manager, Quality Risk Management (QRM) will be responsible for the execution and management of the QRM program elements, including but not limited to, creation of procedures, work instructions, forms / templates, etc., leading / facilitating QRM assessments, collaborating with key stakeholders to ensure all elements of QRM are carried out through established work practices, and ensuring consistent application of QRM system compliance with Astellas local / global procedures and policies, and applicable regulatory requirements. Executes process / continuous improvement and supports new technology initiatives for Astellas. Contributes to and leads in the development, implementation, and successful execution of the QA mission, objectives and 35-year strategic plan. This role is pivotal in driving ongoing improvements in operational efficiency, ensuring that the organization meets its strategic objectives.

Responsibilities

• Execute daily program level responsibilities, including development and implementation of QRM processes and continuous improvements to ensure productivity and alignment with departmental / site / global goals.
• Drive a culture of continuous quality improvement across the organization, leading initiatives that enhance service delivery and patient care.
• Establish and foster a cGMP quality culture that prepares the site for regulatory pre-approval inspections and eventual licensure for commercial manufacturing.
• Manage multiple assigned projects concurrently.
• Build relationships and initiate collaboration with key counterparts, functional area leaders, and stakeholders across campuses to establish and identify process improvement initiatives and to identify, assess, and prioritize risks across all operations, implementing strategies to mitigate these risks effectively.
• Provide support to Manufacturing, Facilities, Supply Chain, and other supporting function stakeholders to ensure QRM processes are utilized as required.
• Prepare and provide comprehensive reports on quality and risk management activities, utilizing performance metrics to identify areas for improvement.
• Assist in the implementation of global systems for the QRM program, including implementation and release of future changes.
• Provide collaboration and guidance for the development and continuous improvement of QRM training to ensure QRM compliance, as well as specialized QRM facilitator training across all GxP functions.
• Provide guidance and support to other BioPharma Quality sites during implementation of QRM program principles to ensure consistent implementation.
• Leads risk assessments to identify and address key quality issues, ensuring risks are escalated and managed appropriately within BioPharma QA.
• Monitors compliance with Health Authority regulations and guidance throughout the product lifecycle, supporting ongoing quality and compliance initiatives in BioPharma.
• 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 process owner for QRM.
• Performs other duties as assigned.