Manager, Quality Operations

Work Schedule

Environmental Conditions

Job Description

Are you ready to lead a dynamic team with diverse skills and make a significant impact? Join us as we strive for excellence in Quality Operations! Reporting directly to the Senior Manager, Quality Operations, you will play a pivotal role in ensuring our compliance with cGMP regulations and company quality standards. You'll guide and coordinate the Quality Operations Team to maintain adherence to site GxP processes.

As the Quality Operation Manager, you'll support manufacturing operations and analytical laboratory activities for Thermo Fisher Ferentino. You will have the responsibility of managing the Quality Operations team, including client specialists, batch record review, investigation, and CAPA management generated by deviations and market complaints. You will also be responsible for managing department performance through critical metrics and continuous improvement processes. The Quality Operation Manager will be supported by a structure that includes different layers of responsibility, including a supervisor, team leaders, and 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.

Requirements:

• 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, Abilities:

• Thorough understanding of pharmaceutical law, quality management systems, and QP duties, as well as 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.

Join us and make a difference! Apply now to be part of a team that values innovation and quality.