Technical Quality Lead

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p>As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.<br /><br />DESCRIPTION:</p><p>The TCS Quality Lead is responsible for ensuring advanced Quality oversight of Technical Operations and Services activities (Engineering &amp; Equipment Validation, Production Maintenance, Utilities Maintenance), ensuring full compliance with cGMP requirements, regulatory expectations, and internal quality standards.</p><p>This role acts as a senior Subject Matter Expert (SME) and provides functional leadership and guidance across TCS Quality processes, with accountability for complex quality topics and critical decision-making.</p><h2></h2><h2><span>Key Responsibilities</span></h2><p><span>Quality Oversight &amp; Functional Leadership</span></p><ul><li><p>Act as the primary Quality reference for TCS-related activities</p></li><li><p>Drive consistency and robustness of Quality processes across TCS</p></li><li><p>Support the Supervisor in defining priorities, KPIs, and continuous improvement initiatives</p></li></ul><p></p><p><b>Audit &amp; Inspection Readiness</b></p><ul><li><p>Lead preparation and management of customer audits and regulatory inspections</p></li><li><p>Act as SME for TCS Quality during inspections</p></li><li><p>Define and monitor post-audit remediation plans</p></li></ul><p></p><p><b>Deviation, CAPA &amp; Change Control</b></p><ul><li><p>Lead and approve complex investigations, including root cause analysis and GMP impact assessment</p></li><li><p>Ensure robustness and effectiveness of CAPA and Change Control processes</p></li><li><p>Monitor KPIs and proactively manage escalations</p></li><li><p>Ensure alignment between technical activities and Quality expectations</p></li></ul><p></p><p><b>Education &amp; Qualifications</b></p><p><b>Education</b></p><ul><li><p>Degree in a scientific or engineering discipline (e.g., Mechanical Engineering, Chemical Engineering)</p></li></ul><p></p><p><b>Experience</b></p><ul><li><p>Minimum 3-5 years of experience in GMP pharmaceutical environment</p></li><li><p>Strong experience in:</p><ul><li><p>Quality Systems (Deviation, CAPA, Change Control)</p></li><li><p>Technical Operations (equipment, utilities, maintenance, validation)</p></li></ul></li><li><p>Experience in sterile manufacturing is highly preferred</p></li></ul><div></div><p><b>Languages</b></p><ul><li><p>Fluent English (written and spoken)</p></li></ul><div></div><p><b>Soft Skills</b></p><ul><li><p>Strong leadership without direct authority (influence-based leadership)</p></li><li><p>Critical thinking and problem-solving</p></li><li><p>Effective communication with cross-functional and senior stakeholders</p></li><li><p>Organizational and prioritization skills</p></li></ul><div></div><p></p><p></p><p></p><p></p>