Data Integrity Manager

Data Integrity Manager

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Join our quality team at Thermo Fisher Scientific, where you'll make a meaningful impact ensuring product quality and regulatory compliance across our pharmaceutical and scientific operations. As a Data Integrity Manager, you'll provide technical leadership and oversight for GMP manufacturing environments, working cross-functionally to drive quality excellence and continuous improvement. You'll serve as a subject matter expert, conducting risk assessments, leading investigations, managing CAPAs, and ensuring adherence to global regulatory requirements. This role offers the opportunity to directly contribute to our mission of enabling customers to make the world healthier, cleaner and safer through robust quality systems and processes.

Note : We are not able to offer relocation assistance for this role at this time.

Essential Functions :

• Assist in preparation of the Data Integrity (DI) Site Governance Team meetings.
• Assist with providing metrics to the Director of the Global Data Integrity network to include pulling data from TrackWise, Audits, Power BI, and other site systems.
• Monitor equipment and instrumentation as indicated in the site data integrity remediation plan and ensure it complies with 21CFR Part 11, Annex 11, and Data Integrity regulations.
• Support and lead Data Integrity initiatives across the site to maintain and proactively improve the data integrity culture.
• Coordinate and track the Data Integrity Remediation Plan to ensure deliverables are on target and executed as committed within the site.
• Provide support on the development of Data Integrity awareness training and compliance with data integrity regulations.
• Create / update procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations.
• Coordinate the DI Surveillance program to audit GMP areas within the site for compliance to establish documentation and data integrity standards, practices, and procedures.
• Collaborate on projects to meet customer, business, and regulatory requirements.
• Present DI Metrics to Site leadership monthly. Provide approvals for DI related deviations, CAPA, and change controls. Assist in data integrity risk assessments.

Job Scope :

Requirements :

Knowledge, Skills, Abilities :

Physical Requirements :

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.