Data Integrity Manager

Thermo Fisher Scientific • Greenville, NC

90d

About The Position

The Data Integrity Manager will be responsible for ensuring flawless data management and compliance across our Greenville site. This outstanding opportunity allows you to lead a multidisciplinary team, ensuring the highest standards of data integrity in both cultural and technical aspects. You will be instrumental in implementing and maintaining compliance with 21CFR Part 11 and Annex 11 regulations. Join us to make a significant impact on our operations and drive outstanding data integrity initiatives!

Requirements

• Bachelor's Degree required, preferably in Science, Engineering, or related fields.
• Minimum of 8 years of experience with a Bachelor's degree, or 6 years with an advanced degree, in quality and data integrity.
• Experience with TrackWise and training preferred.
• Project Management, Supervision, or Management experience required.
• Proven knowledge of cGMP and cGDP.
• Experience with 21CFR Part 11/Annex 11 compliance and TrackWise.
• Proficiency in Microsoft Office Suite.
• Strong written, interpersonal, and presentation skills.
• Ability to manage multiple projects simultaneously.

Responsibilities

• Prepare and facilitate Site Governance Team meetings.
• Provide detailed metrics to site leadership using systems like TrackWise, Power BI, and other site management tools.
• Monitor equipment and instrumentation to ensure strict compliance with 21CFR Part 11, Annex 11, and other regulatory guidelines.
• Lead and support Data Integrity initiatives, proactively improving the site's data integrity culture.
• Coordinate and track the Data Integrity Remediation Plan, ensuring all commitments are successfully met.
• Develop and deliver Data Integrity awareness training.
• Build and maintain procedures aligned with data integrity regulations.
• Coordinate the DI Surveillance program to ensure compliance with documentation standards.
• Collaborate on multidisciplinary projects to meet customer, business, and regulatory requirements.
• Present DI Metrics to site leadership monthly.
• Approve DI-related deviations, CAPA, and change controls.
• Assist in data integrity risk assessments.

Benefits

• Competitive salary
• Annual incentive bonus plan
• 401K with company match up to 6%
• Tuition reimbursement
• Range of other employee benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees