Sr Manager, Validation and DI

Thermo Fisher Scientific•St. Louis, MO

28d

About The Position

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! Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Requirements

Bachelor’s degree in Life Sciences, or a related field.
Minimum of 5 years managing a team.
At least 7 years of experience in data validation, data integrity, or a related domain is required.

Nice To Haves

Master’s degree is desirable.

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.