Sr Manager, Validation and DI at Thermo Fisher Scientific

St Louis, Missouri, United States

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

Requirements

  • Bachelor’s degree in Life Sciences or a related field (Master’s degree desirable)
  • Minimum of 5 years managing a team
  • At least 7 years of experience in data validation, data integrity, or a related domain

Responsibilities

  • Develop and implement comprehensive validation strategies for data systems and processes
  • Develop validation protocols and procedures to guarantee data accuracy and reliability
  • Coordinate data integrity processes to guarantee data accuracy, consistency, and reliability
  • Implement data integrity controls and monitor adherence to these controls
  • Perform routine audits and evaluations of data integrity procedures
  • Guarantee that all data validation and integrity procedures are in line with the company's quality criteria
  • Collaborate with the Quality Assurance team to integrate data integrity into the overall quality management system
  • Engage in quality audits and inspections, offering knowledge on data validation and integrity
  • Ensure compliance with relevant regulatory requirements and industry standards (e.g., FDA, EMA, GxP)
  • Stay informed about updates in regulations and standards impacting data integrity and validation
  • Identify areas for improvement in data management and validation processes
  • Implement guidelines and continuous improvement initiatives to improve data integrity
  • Formulate and present training programs focusing on data integrity and validation practices
  • Instruct employees about the significance of data accuracy and their contribution to upholding it
  • Collaborate closely with IT, Quality Assurance, Regulatory Affairs, and other departments to guarantee data integrity
  • Communicate effectively with collaborators to address data integrity issues and implement solutions
  • Maintain detailed documentation of validation and data integrity processes
  • Compile and deliver reports regarding data integrity status and validation activities to senior management

Skills

Key technologies and capabilities for this role

Validation StrategyData IntegrityGMPGxPFDA ComplianceEMA ComplianceQuality AssuranceAudit ManagementRegulatory ComplianceProcess ImprovementData SystemsValidation Protocols

Questions & Answers

Common questions about this position

What experience is required for the Sr Manager, Validation and DI role?

Candidates need a minimum of 5 years managing a team and at least 7 years of experience in data validation, data integrity, or a related domain. A Bachelor’s degree in Life Sciences or a related field is required, with a Master’s degree desirable.

What is the work schedule and location for this position?

This is a full-time position with a First Shift (Days) schedule, based in the United States. Specific details on remote work or office requirements are not provided.

What education qualifications are needed for this role?

A Bachelor’s degree in Life Sciences or a related field is required, and a Master’s degree is desirable.

What does the company culture emphasize at Thermo Fisher Scientific?

The company focuses on inventing world-class solutions to empower customers in enhancing health, cleanliness, and safety, with a dedicated team of professionals working towards outstanding outcomes.

What makes a strong candidate for this Sr Manager position?

Strong candidates will have 7+ years in data validation or integrity, 5+ years of team management experience, and a relevant degree, along with skills in regulatory compliance (e.g., FDA, EMA, GxP) and collaboration across departments.

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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