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Thermo Fisher Scientific · 22 hours ago

Sr Manager, Validation and Data Integrity

St Louis, MO

Full-time

Onsite

Senior Level

7+ years exp

Thermo Fisher Scientific Inc. is dedicated to inventing world-class solutions for health, cleanliness, and safety. As the Sr Manager, Validation and Data Integrity, you will ensure the accuracy and reliability of data systems while developing validation strategies and managing data integrity processes.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

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

Qualification

Data validationData integrity managementRegulatory complianceQuality assuranceProcess improvementTrainingEducationTeam managementCollaborationDocumentation