Quality Operations Senior Manager

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 focus of the PDS Quality Operations Senior Manager:

Maintain compliance of Quality Operations with cGMP and regulatory standards by respecting prescribed procedures, current laws, and internal quality criteria. Encourage effective and proactive collaboration with site functions and support the development of both individuals and the organization.

Primary responsibilities:

Product Quality

• 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.