Eqms Deployment Lead

As a part of the Business Transformation plan, Dechra is investing in an electronic Quality Management System (eQMS). This cloud-based system will allow all Dechra Business Units in interact with the DPM&S quality assurance business processes across a common platform and process. The business processes include change control, CAPA, deviation, complaints, laboratory investigations, supplier management and audit. The business units that interact with DPM&S on quality assurance are all DVP commercial units (EU, NA and INT) and PDRA.

The purpose of the Deployment Lead is to, with a detailed understanding the eQMS system and the operational state at the various business units, devise and drive a deployment strategy that will allow for seamless adoption of the eQMS system. This role will not be able to accomplish the deployment alone and will, therefore, must work very closely with the Global Quality Leadership Team (GQLT) to ensure that delegated activities are delivered on time. Likewise, the role has the support of both the Head of QMS and Group Quality Director to accomplish the project.

This role is hybrid but you must be able to travel to our Nortwich headquarters when required.

• Participate in configuration workshops as required and working with the QMS Manager to understand the global design of the eQMS.
• Work with the following functional leaders and business units to understand the ways of working at an operational level and identify common deployment strategies that can be implemented across the corresponding area of the business.
• The role will work closely with the corresponding GQLT member ensure that deployment plan is achieved per the plan such as:
  • Internal Manufacturing Quality Director, Site Quality Directors, and Site Directors
  • External Manufacturing Quality Director and external manufacturing managers
  • Head of GDP Operations and the Responsible Persons at the DVP warehouses and applicable sales organisations (i.e., compliant handling)
  • Regulatory Affairs for processes where regulatory input is required.

• Drive the agreed deployment plan and provide routine updates to the Project Coordinator and Head of QMS.
• Maintain a risk register for the deployment activities.
• Create and lead a decentralised team of site / local Deployment Leaders which will track progress on local deployment activities.
• Advise project team on compliance requirements related to the deployment to ensure that the deployment activities do not unintentionally result in non-compliant situations.

• Significant experience in the pharmaceutical industry within a manufacturing and/or laboratory environment including working at an operational level at a pharmaceutical manufacturing organisation.
• A sound understanding of the principles of Quality Risk Management.
• Strong leadership skills with the ability to challenge, influence, and build consensus.
• A strong track record of establishing and maintaining processes/systems which facilitate the delivery of activities to the required quality and regulatory standards.
• In depth knowledge of relevant regulatory agency guidance in relation to technical topics, including FDA, EMA, ICH and authorities in other major geographic areas, is essential.
• Proven ability of accurate and timely completion of tasks.
• Excellent verbal, written and interpersonal communication in English.
• Proven ability to be able to manage changing situations with efficiency, calmness, and purpose with the thought to all parts of the business using knowledge of the business and customers to assist.