Site Quality Lead

Role Description

The Kalamazoo Site Quality Lead role is accountable for product quality and the site's regulatory compliance standing, ensuring adherence to all regulatory compliance requirements and cGMPs, maintaining a state of Inspection Readiness and ensuring a continuous supply of high-quality product from the site.

The Site Quality Lead champions the quality culture and takes proactive steps to ensure a high level of quality and compliance at the site.

The position reports to the Platform Quality Leader.

The Site Quality Lead is a member of the Site Leadership Team and participates in setting the strategic direction of the quality unit and the site as well as managing day to day quality operations. The position also co-chairs the site Quality Council (with the Site Lead) to drive continuous improvement and compliance objectives as well as prioritizing quality culture improvement initiatives.

The role has ownership of the Site Risk Assessment Process - leading the Site Leadership through the process on a predetermined cadence.

The Quality Lead uses data and metrics to drive continuous improvement in site quality management systems as well as Product Quality. Additionally - the role is responsible for creating and executing the Site Quality Roadmap.

Stewardship and Leadership of the Quality Culture within the Quality Function as well as across the Site.

• Establishing and Reinforcing the Quality Culture on the Site; Contributing member of the Site Leadership Team
• Implementation of Quality Standards and ensures sustainability of the Quality Management Systems
• Maintains Site Inspection Readiness for all applicable regulatory agencies including FDA and European Agencies and acts as the company point of contact to lead inspection readiness for the site.
• Ensure that products are manufactured and released in compliance with pertinent Regulatory standards and Registration Files (and requirements of appropriate Regulatory Bodies) and partnering with the regulatory team on all activities relating to regulatory compliance.
• Overall Site Product Quality Stewardship owner and accountability.

Stewardship and Ownership of Site Quality Management System

Staff and Leadership Responsibilities

Organization Relationships

This position will achieve results through Leadership of Colleagues with a direct reporting relationship as well as indirectly through partnership and collaboration with the site Lead and extended site Leadership team and company functions as listed below

Education and Experience

Technical Skills Requirements

Physical Position Requirements

Acronym Definitions

Full time Regular Colleague

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