Senior Data Quality/Integrity Engineer
HumanaFull Time
Senior (5 to 8 years)
North Carolina, United States
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.
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.
Provides life sciences products and services
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.