[Remote] Director, QA Data Integrity at Thermo Fisher Scientific

North Carolina, United States

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Life SciencesIndustries

Requirements

Candidates should possess a Bachelor’s degree or higher in Pharmacy, Engineering, Science, or another applicable degree, along with at least 10 years of experience in pharmaceutical manufacturing or laboratory testing, and confirmed experience leading data integrity programs. They must be proficient in applying 21CFR Part 11, Annex 11, and other relevant regulations.

Responsibilities

The Director, QA Data Integrity will own the Global DI Program, ensuring compliance to regulatory requirements at all Pharmaceutical Services Group (PSG) sites, and drive practical improvements by developing and monitoring Key Performance Indicators. They will also stay current on global regulations and industry trends, update global policies and procedures, assist sites with data integrity risk assessments and remediation plans, analyze metrics, use PPI methodology, support sites with regulatory and client audits, develop training content, and take on other duties as assigned to support the Global Quality Compliance Team.

Skills

Regulatory Compliance
Data Integrity
21CFR Part 11
Annex 11
Program Leadership
KPI Development
Industry Benchmarking
Risk Assessment
Process Improvement
Audit Management

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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