Senior QC Analytics Manager

<h3>Your mission</h3> <p>The main purpose of the Quality Control (QC) Manager is to manage a team of QC analytical scientist/analyst's for the QC release testing and stability testing of gene therapy products and associated materials used for manufacturing to EU and US GMP requirements.</p> <h3>Job Description</h3> <strong>Key Responsibilities</strong><br/><ul><li>Ensure day-to-day management the QC analytical ensuring the laboratory is inspection ready and that any data generated is valid an in compliance with applicable internal and external cGMP requirements.</li><li>Overseeing the Quality Control department to support the quality control release and stability testing of gene therapy products and associated materials.</li><li>Provide line management to members of the QC analytical team to contribute to the overall group objectives and development of staff.</li><li>Develop and manage the site testing schedule to ensure testing is complete by the required timelines. </li><li>Plan and assign work to the team to achieve the most efficient use of personnel and resources.</li><li>Responsible for running and maintaining the QC lab(s) to GMP compliance.</li><li>Manage the stability programme and ensure testing is complete within the required test windows. </li><li>Support any incoming material testing to ensure adequate supply of materials.</li><li>Ensure all quality events (Deviations, CAPA, OOS etc) investigated and closed in timely manner. </li><li>Responsible for reviewing all analytical data generated within the QC analytical team </li><li>Responsible for organising and reviewing testing with 3rd party collaborators.</li><li>Ensure all direct reports or persons are fully trained for tasks they perform and maintain a high standard of record keeping and documentation so that information is clearly captured, disseminated, and reported. </li><li>Support the development, qualification, validation and implementation of analytical methods within QC.</li><li>Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators.</li><li>Contribute to cross departmental activities and providing expert advice and technical input where needed.</li><li>Assure the data integrity of all activities is maintained throughout the data lifecycle.</li><li>Responsible for ensuring that own work, and that of the team, complies with GMP, Good Documentation Practice (GDP) and GxP Data Integrity guidance’s, and is undertaken in accordance with applicable procedures (e.g., SOP’s, Protocols, etc).</li><li>Ensure area compliance with Quality, Safety and Environmental systems and procedures.</li><li>Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.</li><li>Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken.</li><li>Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs &amp; audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.</li><li>Ensure own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved.</li><li>Support with all reasonable senior managerial requests and ad-hoc tasks.</li><li>Support with regulatory documentation and act as key point of contact during inspections.</li><li>Support the Ireland site when necessary.</li></ul><strong>Key Job Competencies</strong><br/><ul><li><u>Analytical </u>- Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs workflows and procedures.</li><li><u>Problem Solving</u> - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.</li><li><u>Change Management</u> - Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.</li><li><u>Technical Leadership</u> - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others with expert knowledge; accepts feedback from others; gives appropriate recognition to others.</li><li><u>Cost Consciousness</u> - works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.</li><li><u>Motivation</u> - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence </li><li><u>Planning/Organizing</u> - prioritizes and p