• Sr Manager, Validation and DI

    ThermoFisher Scientific (St. Louis, MO)


    Work Schedule

     

    First Shift (Days)

     

    Environmental Conditions

     

    Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

    Job Description

    What Makes This Opportunity Unique

     

    At Thermo Fisher Scientific Inc., our objective is to invent world-class solutions that empower our customers to enhance the health, cleanliness, and safety of the world. As the Sr Manager, Validation and DI, you will play a pivotal role in ensuring the accuracy and reliability of our data systems. Join our dedicated team of professionals in the United States and help us achieve outstanding outcomes!

    Job Responsibilities

    Validation Strategy Development

    + Develop and implement comprehensive validation strategies for data systems and processes.

    + Develop validation protocols and procedures to guarantee data accuracy and reliability.

    Data Integrity Management

    + 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.

    Quality Assurance

    + 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.

    Compliance and Regulatory Adherence

    + 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.

    Process Improvement

    + Identify areas for improvement in data management and validation processes.

    + Implement guidelines and continuous improvement initiatives to improve data integrity.

    Training and Education

    + 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.

    Collaboration and Communication

    + 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.

    Documentation and Reporting

    + Maintain detailed documentation of validation and data integrity processes.

    + Compile and deliver reports regarding data integrity status and validation activities to senior management.

    Qualifications

    Education

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

    Experience

    + Minimum of 5 years managing a team.

    + At least 7 years of experience in data validation, data integrity, or a related domain is required.

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.