Manager, Quality Operations

Thermo Fisher Scientific Inc.; Monza; In loco; EUR 50.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading company in the biotechnology sector is seeking a Quality Operation Manager to oversee compliance with cGMP regulations and manage a dynamic Quality Operations team. The successful candidate will require a strong background in pharmaceuticals and leadership in a fast-paced environment, with excellent skills in quality management and regulatory affairs.

Competenze

• Proven experience in a regulated environment (pharmaceuticals, biotech, or medical devices).
• Recognized to act as Qualified Person (QP) per Directive 2001 / 83 / EC is a plus.
• Experience with FDA-approved companies.

Mansioni

• Manage the Quality Operations team and oversee batch record review.
• Ensure compliance with cGMP regulations and manage CAPA for deviations.
• Monitor department performance through critical metrics and drive continuous improvement.

Conoscenze

Leadership

Data Analytics

Problem Solving

Statistical Skills

GMP Regulations

Quality Management Systems

Formazione

Bachelor’s degree in Biology / Biotechnology, Chemistry, or Pharmacy

Strumenti

MS Office

Trackwise

Descrizione del lavoro

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.

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