Data Integrity Manager at Thermo Fisher Scientific

Greenville, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, PharmaceuticalsIndustries

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
Ability to move about office locations and perform physical tasks as needed
Dexterity for typing and using a computer
Visual acuity for reading materials and operating equipment

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
Engage in meetings with cross-functional groups to discuss data integrity
Ensure operations and laboratories align with regulatory requirements
Apply professional concepts to resolve technical issues and lead critical initiatives
Network with key contacts and the Global DI network
Lead and influence teams regarding financial, equipment, standards, and resource needs

Skills

Key technologies and capabilities for this role

TrackWisePower BI21 CFR Part 11Annex 11CAPAChange ControlData IntegrityRisk AssessmentCompliance MonitoringTraining Development

Questions & Answers

Common questions about this position

What compensation and benefits are offered for this role?

The position offers a competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement, and a range of other employee benefits.

Is this a remote position, or where is it located?

This information is not specified in the job description.

What are the key skills and experience required for the Data Integrity Manager role?

Candidates need 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, and the ability to manage multiple projects.

What is the company culture or work environment like for this position?

The role involves leading a multidisciplinary team at the Greenville site in an office environment with a standard Monday-Friday schedule, focusing on compliance, data integrity culture, and collaboration across cross-functional groups.

What qualifications make a strong candidate for this position?

A Bachelor’s Degree in Science, Engineering, or related fields is required, along with 8 years of experience in quality and data integrity (or 6 years with an advanced degree), project management or supervisory experience, and familiarity with TrackWise.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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