QC Manager
Full-timeOncologyBachelors
Description
<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>Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)<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:<br />As a QC Manager, reporting to the Head of QC, lead a Quality Control team (10 to 15 people), while ensuring compliance with cGMP standards and regulatory requirements. As a QC Supervisor at Thermo Fisher Scientific, you'll provide technical leadership and oversight for laboratory operations supporting pharmaceutical manufacturing, from raw materials to finished products. Support operational excellence through mentoring staff, optimizing workflows, and implementing continuous improvement initiatives while maintaining high quality standards.<br /><br />REQUIREMENTS:<br />• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in pharmaceutical/biotech quality control, with 2+ years in a leadership role<br />• Preferred Fields of Study: Chemistry, Biology, Biochemistry, Microbiology or related scientific field</p><p>• Knowledge in cell culture, ELISA, qPCR and molecular biology is a must.<br />• Additional certifications in quality systems, regulatory compliance, or project management beneficial is preferred<br />• Strong knowledge of cGMP, FDA regulations, ICH guidelines and quality systems<br />• Experience with analytical testing methods and instrumentation (HPLC)<br />• Proven ability to lead and develop teams while fostering a quality-focused culture<br />• Strong technical writing skills for SOPs, investigations, and regulatory documentation<br />• Experience managing laboratory operations, including scheduling, resource planning and process improvements<br />• Proficiency with laboratory information management systems (LIMS, SAP) and quality management software are a plus<br />• Excellent project management and organizational skills<br />• Strong interpersonal and communication abilities to interact with all levels of the organization<br />• Experience supporting regulatory audits and inspections<br />• Demonstrated problem-solving skills and ability to lead investigations<br />• Working knowledge of data integrity principles and documentation requirements<br />• Ability to prioritize multiple responsibilities while maintaining high quality standards<br />• Experience with risk assessment and root cause analysis<br />• Proficiency with Microsoft Office applications<br />• Flexibility to adjust schedules as needed to support manufacturing operations</p><p>• Fluent level of French and high-intermediate level of English are a must</p><p></p><p></p><p></p><p></p>
Pipeline
Retrospective Cohort EnrollmentN/A
Technical Evaluation of Brahms PCT DirectN/A
Blood sample collectionN/A
Blood samplingN/A
RimegepantN/A