Ph3Overview /h3 pbManager, Quality Operations /b role at bThermo Fisher Scientific /b /p pReporting 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. /p pAs 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. /p pThis 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. /p h3Responsibilities /h3 ul liLead the Quality Operations Team to ensure compliance with cGMP regulations and company quality standards. /li liSupport manufacturing operations and analytical laboratory activities for Thermo Fisher Ferentino. /li liManage the Quality Operations team, including client specialists, batch record review, investigations, and CAPA management generated by deviations and market complaints. /li liMonitor department performance through critical metrics and drive continuous improvement efforts. /li liProvide guidance within a structured team with roles including supervisor, team leaders, and QO lead. /li /ul h3Qualifications /h3 ul liMinimum Bachelor’s degree in a chemical, scientific, or technical field such as Biology/Biotechnology, Chemistry, or Pharmacy. /li liProven experience in a similar position within a regulated environment such as pharmaceuticals, biotech, or medical devices. /li liPreferably recognized by Regulatory Authority to act as Qualified Person (QP) per Article 49 of Directive 2001/83/EC. /li liExpertise in GMP regulations (EU and US). /li liIn-depth knowledge of sterile injectable drug production processes. /li liExperience with Pharma FDA-approved companies. /li liProficiency in MS Office (Minitab is a plus). /li liExtensive experience with Pharmaceutical Quality Systems (e.g., Trackwise) and reporting tools. /li liExcellent proficiency in English. /li /ul h3Knowledge, Skills, and Abilities /h3 ul liThorough understanding of pharmaceutical law, quality management systems, and QP duties, with deep understanding of manufacturing and supply chain processes. /li liStrong mathematical and statistical skills and proficiency in data visualization, data analytics, and continuous improvement. /li liExperience in quality event management. /li liManufacturing and validation environmental experience. /li liProven leadership skills with experience managing direct reports. /li /ul h3Seniority level /h3 ul liNot Applicable /li /ul h3Employment type /h3 ul liFull-time /li /ul h3Job function /h3 ul liQuality Assurance, Product Management, and Engineering /li /ul h3Industries /h3 ul liPharmaceutical Manufacturing and Biotechnology Research /li /ul pWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. /p /p #J-18808-Ljbffr