Manager, Quality Operations at Thermo Fisher Scientific

Ferentino, Latium, Italy

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Medical DevicesIndustries

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

Responsibilities

Manage the Quality Operations Team, including client specialists, batch record review, investigation, and CAPA management
Ensure adherence to site GxP processes and cGMP regulations
Support manufacturing operations and analytical laboratory activities
Manage department performance through critical metrics and continuous improvement processes
Lead and support quality event management
Apply strong mathematical and statistical skills and proficiency in data visualization and analytics
Provide knowledge, skills, and abilities related to pharmaceutical law, quality management systems, and QP duties
Experience in manufacturing and validation environmental processes

Skills

cGMP

GMP

GxP

CAPA

Batch Record Review

Deviation Investigation

Market Complaints

Qualified Person (QP)

Sterile Injectables

Quality Operations

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.

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