Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
Top Skills
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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