Quality Operations Senior Manager

Job Overview

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Explore an outstanding opportunity at Thermo Fisher Scientific Inc. as a Pharmaceutical Development Services Quality Operations Senior Manager! Join a world-class team at our Monza site, where we strive for flawless execution and aim to make a significant impact on a global scale.

Primary responsibilities

• Manage reporting structure for Quality On The Floor and Quality Operations staff, ensuring accurate review of production, documentation, CoAs, and investigations in compliance with cGMPs, registration, and client needs.
• Act as the Qualified Person in product disposition and issues assessment.
• Guarantee adherence to corporate quality standards.
• Guarantee the surveillance of on-shift production activities (overlooking and fit&finish in production area), to proactively increase the Quality Culture within the Departments.

Operations

• Ensure support to site operations to meet cGMP requirements and Corporate Standards.
• Facilitate efficient interactions with clients to ensure the respect of Quality Agreements and to develop business.
• Assist with operations performance reviews, identify issues, recommend solutions, and ensure follow-up.

Compliance

• Aid in comparing gaps to GMP rules, updating guidelines, and planning corrective actions for GMP compliance.
• Support the site Regulatory Inspections to ensure that each inspection is accurately and effectively handled.

Budget

• Assist the Supervisor with budget preparation, providing necessary data and proposals following corporate standards.

Personnel and organization management

• Manage performance and development of collaborators to ensure achievement of personal and site goals as well as a "great place to work" environment.
• Lead the organization by setting goals, evaluating results, analyzing training needs to ensure commitment and motivation.
• Guarantee that both the initial and the continuous training of the department personnel are performed and is suited to the needs.

Requirements

• Academic background in a chemical, scientific, or technical field such as Biology/Biotechnology, Chemistry, or Pharmacy.
• Validated experience in a similar position within a regulated environment such as pharmaceuticals or biotech.
• Highly preferable 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 and Italian.

Knowledge, Skills, Abilities

• Detailed understanding of pharmaceutical law, quality management systems, and QP duties, as well as deep understanding of manufacturing and supply chain processes.
• Experience in quality event management.
• Confirmed leadership skills with experience leading direct reports in a matrix complex organization.