Overview Manager, Quality Operations role at Thermo Fisher Scientific Reporting directly to the Senior Manager, Quality Operations, you will play a pivotal role in ensuring compliance with cGMP regulations and company quality standards. You will guide and coordinate the Quality Operations Team to maintain adherence to site GxP processes. As the Quality Operations Manager, you will support manufacturing operations and analytical laboratory activities for Thermo Fisher Ferentino. You will manage the Quality Operations team, including client specialists, batch record review, investigations, and CAPA management generated by deviations and market complaints. You will also manage department performance through key metrics and continuous improvement processes. The team structure includes a supervisor, team leaders, and a QO lead. This role requires a transformational leader with the drive and interpersonal skills to thrive in a fast-paced, growth-oriented environment. We are committed to equal opportunities and welcome applications from all qualified candidates. Responsibilities Lead the Quality Operations Team to ensure compliance with cGMP regulations and company quality standards. Support manufacturing operations and analytical laboratory activities for Thermo Fisher Ferentino. Manage the Quality Operations team, including client specialists, batch record review, investigations, and CAPA management generated by deviations and market complaints. Monitor department performance through critical metrics and drive continuous improvement efforts. Provide guidance within a structured team with roles including supervisor, team leaders, and QO lead. Qualifications Minimum Bachelor’s degree in a chemical, scientific, or technical field such as Biology/Biotechnology, Chemistry, or Pharmacy. Proven experience in a similar position within a regulated environment such as pharmaceuticals, biotech, or medical devices. Preferably recognized by Regulatory Authority to act as Qualified Person (QP) per Article 49 of Directive 2001/83/EC. Expertise in GMP regulations (EU and US). In-depth knowledge of sterile injectable drug production processes. Experience with Pharma FDA-approved companies. Proficiency in MS Office (Minitab is a plus). Extensive experience with Pharmaceutical Quality Systems (e.g., Trackwise) and reporting tools. Excellent proficiency in English. Knowledge, Skills, and Abilities Thorough understanding of pharmaceutical law, quality management systems, and QP duties, with deep understanding of manufacturing and supply chain processes. Strong mathematical and statistical skills and proficiency in data visualization, data analytics, and continuous improvement. Experience in quality event management. Manufacturing and validation environmental experience. Proven leadership skills with experience managing direct reports. Seniority level Not Applicable Employment type Full-time Job function Quality Assurance, Product Management, and Engineering Industries Pharmaceutical Manufacturing and Biotechnology Research We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. J-18808-Ljbffr