Lead, Data Quality/Integrity - HEDIS Supplemental Data
HumanaSalary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
[Remote] Director, QA Data Integrity at Thermo Fisher Scientific
North Carolina, United States
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Life SciencesIndustries
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this position remote?
Yes, this is a remote position.
What is the salary for this role?
This information is not specified in the job description.
What experience and skills are required for this position?
Candidates need a Bachelor’s Degree or higher in Pharmacy, Engineering, Science, or related field, 10+ years in pharmaceutical manufacturing or laboratory testing, confirmed experience leading data integrity programs, and proficiency in 21CFR Part 11, Annex 11, and other regulations. Key skills include leadership to influence multidisciplinary staff, problem-solving for complex technical issues, and ability to work independently remotely.
What does the work environment or culture look like at Thermo Fisher Scientific for this role?
The role involves leading a Global Community of Practice for information sharing, driving practical process improvements using PPI methodology, and engaging with industry groups like PDA and ISPE, suggesting a collaborative, innovative, and compliance-focused culture.
What makes a strong candidate for the Director, QA Data Integrity role?
A strong candidate will have confirmed experience leading data integrity programs, deep regulatory knowledge including 21CFR Part 11 and Annex 11, proven leadership in multidisciplinary teams, and the ability to work independently remotely while driving improvements and KPIs.
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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