Quality Operations Senior Manager at Thermo Fisher Scientific

Monza, Lombardy, Italy

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

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
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

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

Skills

cGMP

GMP

Quality Operations

Product Disposition

Qualified Person

Regulatory Inspections

Quality Assurance

CoA Review

Investigations

Production Oversight

Quality Culture

Budget Preparation

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

Land your dream remote job 3x faster with AI

Try Jobo Free