Team Leader- EMA Instrument Software Management at Thermo Fisher Scientific

Zaventem, Flanders, Belgium

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Life Sciences, PharmaceuticalsIndustries

Requirements

  • Perform system risk assessments
  • Create system validation test cases and testing summary reports
  • Create system diagrams
  • Familiar with EMA and other regulatory guidelines
  • Manage team members globally
  • Client facing experience
  • Audit support experience
  • Can be located in either US/Belgium location

Responsibilities

  • Provide client facing support
  • Provide audit support

Skills

Key technologies and capabilities for this role

system risk assessmentssystem validation test casestesting summary reportssystem diagramsEMA regulatory guidelinesteam managementclient facingaudit support

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time employment position.

Where can I be located for this role?

The role can be located in either the US or Belgium.

What skills are required for this Team Leader position?

Required skills include performing system risk assessments, creating system validation test cases and testing summary reports, creating system diagrams, familiarity with EMA and other regulatory guidelines, managing team members globally, client-facing experience, and audit support experience.

What is the work schedule and environment like?

The work schedule is standard Monday-Friday in an office environment.

What makes a strong candidate for this role?

A strong candidate will have hands-on experience with system risk assessments, validation testing, regulatory guidelines like EMA, global team management, client-facing interactions, and audit support.

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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